3748 Pharma Jobs - Page 19

Let s do this. Let s change the world. The Manager of Business Performance will lead a team focused on leveraging data and analytics to drive strategic decision-making and operational excellence. This role is responsible for overseeing performance measurement frameworks, developing advanced analytics capabilities, and ensuring alignment between business goals and data-driven insights. The ideal candidate will combine strong leadership skills with deep analytical expertise and a solid understanding of data technologies. The Manager of Business Performance offers a unique opportunity to join a fun, innovative engineering team within the Enterprise Data Strategy and Engineering (EDSE) organization. You ll work on building next-generation capabilities and services in Data and AI using innovative open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, ensuring alignment with organizational priorities. The Manager of Business Performance will lead a team focused on leveraging data and analytics to drive strategic decision-making and operational excellence. This role is responsible for overseeing performance measurement frameworks, developing advanced analytics capabilities, and ensuring alignment between business goals and data-driven insights. The ideal candidate will combine strong communication skills with deep analytical expertise and a solid understanding of insights generation from data. Develop and implement business performance strategies, KPIs, and reporting frameworks. Manage a team of analysts to deliver high-impact insights and performance dashboards. Collaborate with cross-functional teams to identify performance gaps and provide recommendations. Design and delivery of executive-level reports and presentations. Ensure data compliance across performance reporting systems. Drive continuous improvements in reporting. Partner with different teams to get the data and produce insights for the leaders out of it. What we expect of you Minimum 8 to 11 years of Experience business performance Basic Qualifications: Lead a team of analyst to provide business insights about the ongoing projects and of overall departmental work to the leaders. Understanding of different KPIs/metrics (operational, projects and financials) and ability to track, monitor and report those. Know the frameworks and visualization methods to present the business progress to the leaders. Good analytical skills. Proficiency with data tools (e.g. excel, power bi, Tableau etc) Experience in communication and presentation to leadership. Excellent stakeholder management skills. Excellent communication and social skills, with the ability to work collaboratively with different teams. Preferred Qualifications: Ability to work effectively across matrixed organizations and lead in collaboration. Passion for technology and customer success, particularly in driving innovative AI and data solutions. Familiarity with biotech/pharma is beneficial. Soft Skills: Excellent analytical and solving skills. Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to handle multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Compliance Job Description Job Summary : Experienced Privacy Professional to work in the Worldwide Compliance & Business Ethics (WC&BE) Department of a global Pharmaceutical/biotechnology headquartered in Southern California. The individual will be located in Hyderabad and support Amgen s Privacy Compliance program in Asia and be part of the international privacy compliance team. The individual will report directly to the Chief Privacy Officer . Roles and Responsibilities : Provide advice, guidance and/or support to local Compliance professionals regarding: Any data protection issues arising at respective affiliates Data Protection Authority (DPA) Notifications and Prior Approval submissions Data Subject Inquiry responses (including access requests and requests for correction or deletion) DPA inquiries and inspections (including advising on filing of DPA Notifications etc.) Audit preparation and remediation Regional execution of timely self-assessments to detect Privacy and Data Protection gaps and communicate gaps to Head of Global Privacy immediately (including liaising with business partners and IS to remediate self-assessments and audit gaps) Any needed privacy-related training Provide advice, guidance and/or support to Global Privacy Compliance team regarding: Regional or local privacy regulations and DPA activities regarding relevant regions Local and/or regional privacy risks Status of the Privacy Compliance program in respective countries on a regular basis Cross-borders issues and assist in the development and implementation of solution-oriented approaches to Privacy and Data Protection compliance in assigned region and across Amgen Best practices and how to improve cross-geographical and cross-functional awareness of Privacy and Data Protection Implementation and identifying any needed improvements in Privacy Incident Response process in regional affiliates in assigned region Enable privacy compliance across various functions by: Providing training together with the WC&BE team, and regular communications on Privacy and Data Protection Compliance to relevant staff Advising on Privacy and Data Protection issues, including drafting privacy notices, templates and consents, and ensuring consistency in practices and forms across regions; and Collaborating with Law, Corporate Audit, Information Systems and WC&BE functions regarding Privacy and Data Protection requirements to enable compliance and programmatic improvement. Minimum Requirements : LLB or equivalent degree with at least 10 years of legal and/or privacy and data protection experience at a global company in a regulated industry (biopharmaceutical experience preferred), with deep expertise in Privacy and Data Protection. Proven ability to effectively and timely manage multiple initiatives and cross departmental projects (i.e., strong project management skills) Demonstrated ability to communicate well with business leadership, information systems professionals and compliance professionals to drive workable solutions Proven ability to balance multiple priorities simultaneously, and to thrive and deliver in a highly regulated and fast-paced corporate environment Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape Ability to deal well with ambiguity and complex situations Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude depending on the audience Demonstrable acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities Proven communication, relationship-building and collaboration skills Experienced in crisis management and handling Proven commitment to delivering quality and timely output Ability to work with key partners to ensure coordination of activities and alignment between security and privacy programs Strong strategic thinking skills and ability to translate strategy into action plans Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries Ability to understand, plan and navigate in a matrixed environment Excellent command of English (spoken and written) and public speaking skills Availability in crisis Appreciation of global context of local or regional activities Additional Competencies/Skills: Effective leadership skills Effective organizational and creative problem-solving skills Self-starter with a high level of initiative and strong work ethic Strong understanding of the role of compliance professionals CIPP certification from the International Association of Privacy Professionals (IAPP) (preferred) High level of integrity in all actions. .

Let s do this. Let s change the world. We are seeking a Associate Director of ML / AI Engineering to lead Amgen India s AI engineering practice. This role is integral to developing top-tier talent, setting ML / AI best practices, and evangelizing ML / AI Engineering capabilities across the organization. The Associate Director will be responsible for driving the successful delivery of strategic business initiatives by overseeing the technical architecture, managing talent, and establishing a culture of excellence in ML / AI The key aspects of this role involve : (1) prior hands-on experience building ML and AI solutions (2) management experience in leading ML / AI engineering team and talent development (3) Delivering AI initiatives at enterprise scale Roles & Responsibilities: Talent Growth & People Leadership: Lead, mentor, and manage a high-performing team of engineers, fostering an environment that encourages learning, collaboration, and innovation. Focus on nurturing future leaders and providing growth opportunities through coaching, training, and mentorship. Recruitment & Team Expansion: Develop a comprehensive talent strategy that includes recruitment, retention, onboarding, and career development and build a diverse and inclusive team that drives innovation, aligns with Amgens culture and values, and delivers business priorities Organizational Leadership: Work closely with senior leaders within the function and across the Amgen India site to align engineering goals with broader organizational objectives and demonstrate leadership by contributing to strategic discussions Create and implement a strategy for expanding the AI/ML engineering team, including recruitment, onboarding, and talent development. Oversee the end-to-end lifecycle of AI/ML projects, from concept and design through to deployment and optimization, ensuring timely and successful delivery. Ensure adoption of ML-Ops best practices, including model versioning, testing, deployment, and monitoring. Collaborate with multi-functional teams, including product, data science, and software engineering, to find opportunities and deliver AI/ML solutions that drive business value. Serve as an AI/ML evangelist across the organization, promoting awareness and understanding of the capabilities and value of AI/ML technologies. Promote a culture of innovation and continuous learning within the team, encouraging the exploration of new tools, technologies, and methodologies. Provide technical leadership and mentorship, guiding engineers in implementing scalable and robust AI/ML systems. Work closely with collaborators to prioritize AI/ML projects and ensure timely delivery of key initiatives. Lead innovation initiatives to explore new AI/ML technologies, platforms, and tools that can drive further advancements in the organization s AI capabilities. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 12 to 14 years of computer science, Artificial Intelligence, Machine Learning experience OR Bachelor s degree and 14 to 18 years of computer science, Artificial Intelligence, Machine Learning experience OR Diploma and 18 to 20 years of computer science, Artificial Intelligence, Machine Learning experience Preferred Qualifications: Experience in building AI Platforms & applications at enterprise scale Expertise in AI/ML frameworks and libraries such as TensorFlow, PyTorch, Scikit-learn, etc. Hands-on experience with LLMs, Generative AI, and NLP (e.g., GPT, BERT, Llama, Claude, Mistral AI ) Strong understanding of MLOps processes and tools such as MLflow, Kubeflow, or similar platforms. Proficient in programming languages such as Python, R, or Scala. Experience deploying AI/ML models in cloud environments (AWS, Azure, or Google Cloud). Proven track record of managing and delivering AI/ML projects at scale. Excellent project management skills, with the ability to lead multi-functional teams and manage multiple priorities. Experience in regulated industries, preferably life sciences and pharma Good-to-Have Skills: Experience with natural language processing, computer vision, or reinforcement learning. Knowledge of data governance, privacy regulations, and ethical AI considerations. Experience with cloud-native AI/ML services (Databricks, AWS, Azure ML, Google AI Platforms) Experience with AI Observability Professional Certifications (Preferred): Google Professional Machine Learning Engineer, AWS Certified Machine Learning, or Azure AI Engineer Associate, Databricks Certified Generative AI Engineer Associate Soft Skills: Excellent leadership and communication skills, with the ability to convey complex technical concepts to non-technical collaborators. Ability to foster a collaborative and innovative work environment. Strong problem-solving abilities and attention to detail. High degree of initiative and self-motivation. Ability to mentor and develop team members, promoting their growth and success. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

This is a technical role responsible for managing complex server environments, including ORACLE and Postgres databases. The role includes planning, implementation, performance tuning, and maintenance of enterprise relational database platforms with a focus on reliability, security, and automation.. The ideal candidate will have a consistent track record in database infrastructure operations and have a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a solid background in database service delivery and operations, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Please note, this is an on-site role based in Hyderabad. Provide database administration support for development, test and production environments including installation, upgrades, performance optimization, decommissions as well as managing requests and incidents for Oracle databases Administer security access controls following all standard operating procedures Recover databases in case of disaster recovery support Follow, review and recommend updates of support documentation as needed Recommend automation opportunities for operational work and process improvements. Collaborating with technical leads on database design decisions to ensure applications have high levels of performance, security, scalability, maintainability and reliability Investigate and resolve technical database issues. Participate in rotational 24x7 On-Call Support and assist root cause analysis when applicable Perform necessary security patch implementations to ensure ongoing database security Understanding of how to support and use NAS storage and cluster technologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of Information Systems and Database Administration experience OR Bachelor s degree and 3 to 5 years of Information Systems and Database Administration experience OR Diploma with 7 to 9 years of Information Systems and Database Administration experience Experience administering Oracle Database and related services & monitoring systems Demonstrable experience automating database provisioning, patching and administration Experience with various DB toolsets to review performance, monitoring and solving issues Understanding of ITIL frameworks and standard processes Understanding of operating system tools for performance and solving issues Excellent data-driven problem solving and analytical skills Demonstrable experience as part of a high-performance team Preferred Qualifications: Experience supporting Oracle RAC and Data Guard Experience working on regulated systems (preferably in the pharmaceutical sector) Good communication skills Change management knowledge Experience using Ansible for automation Experience supporting PostgreSQL databases Professional Certifications: Database certifications (OCA) (preferred) Soft Skills: Detail-oriented and organized Effective communicator Ability to follow procedures accurately Willingness to learn and grow Shift Information: This position is required to be onsite and participate in 24/5 and weekend on call in rotation fashion and may require you to work a later shift. Candidates must be willing and able to work off hours, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Group Purpose The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the robust safety strategy and deliverables for each Amgen product. The group collaboratively drive excellence in patient safety by leading signal detection, management activities, and risk management practices, including Risk Evaluation and Mitigation Strategies (REMS). Through the definition and implementation of innovative policies, research initiatives, and best practices in safety science, the teams ensure comprehensive benefit-risk assessments, effective safety communications, and adherence to quality processes supported by measurable metrics. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. Let s do this. Let s change the world. In this vital role you will oversee all signal management activities and staff in the Safety Sciences Team at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leadership attribute with a deep understanding of drug safety and pharmacovigilance, signal detection and management, safety data analyses, risk management and people leadership/ management, along with experience in innovation and technology. This staff member will provide leadership to the Safety Sciences Team, consisting of staff based in India working across multiple therapeutic areas and signal management, while reporting into the GPS AIN Lead. Key Activities Provide direction, strategy and leadership for signal detection and management activities at the India site Provide managerial leadership to the safety sciences team allowing appropriate prioritization of resources to achieve GPS goals. Regular communication with the global team to discuss product and/or process issues. Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff Ensure staff are compliant with Amgen corporate and departmental training Disseminate relevant information to teams as appropriate Ensures smooth and collaborative interactions with all other Safety groups Provides relevant input on technical processes in the department and contributes to continuous improvement initiatives across GPS Accountable for delivery against goals assigned to group Participate in budget and headcount planning Establish effective, collaborative interfaces with partners outside of GPS e.g. tech to ensure GPS needs are being met with respect to signal management Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Medical degree and 6 years of directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. Minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 3 years of functional management experience overseeing PV staff A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective Leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to timelines Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master s/ Doctorates degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Regulatory Job Description Let s do this. Let s change the world. In this vital role you will report into the Regulatory Compliance Team lead. The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Manager include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies Provides expertise and guidance to interdepartmental and cross-functional teams Coaches and support junior regulatory staff s career development Identifies and implements process improvements for the change management process What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Regulatory Job Description The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master s degree OR Bachelor s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry .

The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a critical role in ensuring that our research and development activities are conducted in an ethical and responsible manner . CRQ is responsible for ensuring that our research and development activities meet the highest standards of quality and compliance, ultimately keeping patients safe, protecting their welfare, while ensuring that all data produced has integrity. In this vital role , the Quality Compliance Senior Manager will contribute to providing leadership to ensure excellence in R&D Quality Processes is maintained through oversight and improvements when compliance issues are identified In addition, this role will serve as a mentor for Amgen staff in India who will be working to advance the Quality System, and they will act to manage day to day activities for the team. They will be an integral team member working globally with Business Process Owners to ensure compliance with regulations and other business requirements. This role will be part of supporting the digital quality management system (DQMS) as a Subject Matter Expert ( SME ) to support the core processes managed in Quality. Additionally, the Quality Compliance Senior Manager will provide proactive end to end quality support for the management of Quality Incidents/Quality Events , working closely with Quality Leads in approving investigations , including root cause analysis (RCA) and C orrective & Preventive Action (C APA ) plans. Roles & Responsibilities: The Quality Compliance Senior Manager will work both independently and in a team environment to foster collaborative relationships with in R&D Quality. In this vital role , they will be responsible for supporting processes and operational activities related to ; overseeing deviations, preparation of audits and inspections across R&D Quality including Good Pharmacovigilance Practice ( GPvP ), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). As part of strengthening and advancing Amgen s R&D QMS, this role provides end-to-end quality support to Deviation owners, RCA owners, and CAPA owners. Manages the Amgen India R&D Quality team to ensure that the team is supported and managed on a day-to-day basis. Support s the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation. Facilitate s timely and thorough deviation investigations in collaboration with functional area r epresentatives and Quality Leads. E nsure s consistent and compliant documentation of deviation records within the electronic quality management system ( D QMS). Monitor s and ensure s adherence to timelines, escalating delays and risks as needed. Support s Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners Identif ies , lead s , or contribute s to continuous improvement initiatives to enhance CAPA management practices. Collaborate s with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations. Ensure s the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles. Monitor s quality metrics and key performance indicators (KPIs) related to deviation and CAPA management. Analyses trends and perform root cause trending to identify systemic issues and opportunities for process improvement. Manage s , organize s and analyse s data through different systems, tools, or platforms, including Excel and Smartsheet Maintain s knowledge of current regulatory and quality practices/issues Maintain s the Global R&D CRQ and SMQ SharePoint sites Manage s the appropriate archival and retention of audit documentation. Basic Quali fi cations and Experience: Master s degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred Additional Competencies/Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx ) Good team building skills and the ability to on-board new employees and develop them over time Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP . Experience working in a multinational environment with global teams. Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure

Let s do this. Let s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. The Product Analyst position offers a unique opportunity to join a fun, innovative engineering team within the Enterprise Data Strategy and Engineering (EDSE) organization. You ll work on building next-generation capabilities and services in Data and AI using innovative open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, ensuring alignment with organizational priorities. We are seeking a detail-oriented and analytical Product Analyst with a strong background in Business Intelligence (BI) and reporting to support data-driven decision-making across our product teams. You will be responsible for gathering requirements for transforming data into actionable insights, building dashboards, and collaborating with cross-functional teams to enhance product performance and user experience. You will work closely with business team and you will need to play a key role in the Go-to-Market (GTM) strategy, ensuring seamless product launches, aligning messaging with customer needs. Acting as the Voice of the Customer, you will collaborate internally within Product Management and with Product Engineering, and the GTM teams to drive product adoption and deliver optimal outcomes Help design, develop, and maintain BI dashboards and reports using tools like Power BI, Tableau, or Looker. Collaborate with business, product managers, engineers, and stakeholders to define KPIs and success metrics. Translate business requirements into technical specifications for reporting and analytics Customer Insights & Experience: Develop a deep understanding of both data and related metrics to help customer with best possible representation of reports and dashboards Engage directly with customers at key touchpoints, gaining insights into their interactions with BI reports and dashboards. Build and foster an active user community, facilitating knowledge-sharing and enhancing the adoption of data and AI products. Go-to-Market (GTM) Strategy: Collaborate with Product Management to implement comprehensive GTM strategies for data and AI products. Align GTM messaging and product positioning with organizational needs, enabling effective adoption and broader applicability of solutions Support the launch of new products and features, working closely with multi-functional teams to ensure GTM plans are well-executed and drive product adoption. Support & Advocacy: Provide Last Mile Support and Solutions on Demand for both data, ensuring prompt resolution of customer challenges and delivering a seamless user experience. Assist in user onboarding and training, ensuring users fully understand how to demonstrate the platform s data capabilities. Identify and develop brand ambassadors within the customer base to advocate for the product s unique benefits. Provide targeted support for unique business requirements, enabling seamless integration of data capabilities into broader operational frameworks Product Performance & Data Analysis: Monitor and analyze product performance metrics using advanced analytics to gain insights into customer behavior and product usage. Work closely with engineering, product management, and other teams to ensure the successful execution of product goals, focusing on data, analytics, and AI-driven innovations. The insights and optimizations from product analytics will ensure alignment with overarching business goals and operational priorities, supporting scalable and impactful outcomes. What we expect of you Any degree and 8 to 13 years of experience in relevant field Basic Qualifications: 8-13 years of experience in a product analyst role, especially with BI reporting and dashboards, and a focus on GTM execution. Worked with different BI tools such as Power BI, Tableau etc. Experience of working closely with data engineering. Experience in GTM strategy development and execution, with a track record of supporting product launches and ensuring right dashboards are provided. Strong skills in Excel and hands-on experience with Agile methodologies (Scrum/SAFe). Excellent communication and social skills, with the ability to work collaboratively with cross-functional GTM, product, and engineering teams. Knows SQL. Preferred Qualifications: Have worked on BI tools previously.. Familiarity with data transformations, visualizations, AI platforms, and cloud-based data solutions. Ability to work effectively across matrixed organizations and lead collaboration between data and AI teams. Passion for technology and customer success, particularly in driving innovative AI and data solutions. Experience in services or consulting related to data and AI products is a plus, and familiarity with biotech/pharma is beneficial. Soft Skills: Excellent analytical and solving skills. Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to handle multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and alignment to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Involve actively in release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Assist with UAT, test data preparation and developing work instructions. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow best QA practices Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Find opportunities for process improvements in validation activities. Know the latest on new technologies, validation trends, and industry standard processes to improve validation efficiencies. Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years of experience in Software Quality and GMP Validation Preferred Qualifications: Functional Skills: Must-Have Skills: Experience in Quality Assurance (QA) testing with experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). Overall experience in developing, executing and analyzing QA & Test Automation Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Experience with computer system validation and software validation. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will be responsible for leading and charting the course for the Quality Control technology product team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. The ideal candidate will have a proven track record of leadership in technology-driven environments for the Quality Control area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a solid background in end-to-end software development and Quality Control Platforms, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the partners feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Attract and recruit top talent as part of an extensive Technology organization to be hired within India. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute in a professional we seek with these qualifications Basic Qualifications: Master s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills Demonstrated experience in handling technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to handle multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively handle collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. GMP and Validation Experience on Pharmaceutical / Regulated Industry Experience with Managing Quality Control Platforms on a Global Enterprise Environment Have good eye for business. Can demonstrate deep understanding of industry, therapy and product Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Knowledge on Investigational Methodologies and Technical Writing Proficiency Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and fix skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Safety Job Description Job Summary Responsible for performing adverse event/product complaints correlation analysis and post market surveillance and perform literature and regulatory intelligence review. Prepare and provide metrics for management reviews, as well as data pulls and applicable sections for Global Periodic Aggregate Safety Reports, Device Periodic Safety Update Reports (PSUR), Medical Device Regulation (MDR) and Clinical Evaluation Reports (CER). Roles and Responsibilities Key Activities Working under the supervision of the Post Market Surveillance and Trending Lead, the Combination Product & Medical Device Safety Vigilance Specialist will be responsible for: Regulatory Intelligence Review Review Regulatory updates from GPS PV Intelligence for impact to Combination Product Safety (CPS). Literature Review Perform the review of literature search results for the applicable devices. Post-Product Risk Periodic Review Pull data from database review AEs and evaluate any changes to P2 values. External Safety Data Review Pull data from MAUDE (FDA Manufacturer and User facility device experience) and FAERs database. Product Complaint (PC) Trending Correlation with Adverse Events (AE) Evaluate AEs co-reported with PC excursions identified from monthly PC holistic review to assess impact to patient and user safety (i.e., safety concerns or new harms). Reconcile AE lot excursions with PC lot excursions to support PC trending deep dives Post-marketing Surveillance of Combination Products and Medical Devices Pull data to support post marketing surveillance activities for combination products and medical devices. Metrics Pull, analyze and provide metrics for various governance forums. Support audits and inspections, as appropriate. Required Knowledge and Skills: Safety experience in biotech or pharmaceutical industry. Complaints or complaints trending within a development, manufacturing, or post-market environment. Knowledge of product complaints and adverse events intake and processing process. Ability to pull and analyse product complaints and/or adverse events data per request. Knowledge of medical devices or combination products, including device safety monitoring regulations and standards. Very strong knowledge of post market safety reporting regulations for medical devices/combination products globally. Data querying skills and experience with data visualizations tools such as Tableau, Power BI, or Python. Excellent interpersonal and teamwork skills. Critical scientific thinking and problem solving with attention to detail. Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint). Preferred Knowledge and Skills: Knowledge of combination products and medical devices, including device safety monitoring regulations and standards. Ability to perform data analysis and derive insights. Organizational savvy and ability to operate effectively in a matrix environment. Prioritization and time management skills. Basic Qualifications: Doctorate degree and 8+ years of Post market surveillance and data analysis experience OR Master s degree or Bachelor s degree and 9+ years of Post market surveillance and data analysis experience .

Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

In this vital role, you will develop data & analytics capabilities for the Global Quality organization. In this role, you will lead technical delivery as part of a team of data engineers and software engineers. The team will rely on your leadership to own and refine the vision, feature prioritization, partner alignment, and experience leading solution delivery for Amgen. You will drive the software engineering side of the product release and will deliver for outcomes. Roles & Responsibilities: Lead delivery of overall product and product features from concept to end of life management of the product team, comprised of engineers, product owners, and data scientists to ensure that business, quality, and functional goals are met with each product release Drives excellence and quality for product releases, collaborating with partner teams Hands-on experience with rapid prototyping and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Incorporate and prioritize feature requests into product roadmap; Able to translate roadmap into execution Design and implement usability, quality, and delivery of a product or feature Plan releases and upgrades with no impacts to business Hands on expertise in driving quality and best in class Agile engineering practices Encourage and motivate the product team to deliver innovative and exciting solutions with an appropriate sense of urgency Manages progress of work and addresses production issues during sprints Communication with partners to make sure goals are clear and the vision is aligned with business objectives Direct management and staff development of team members What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree in computer science or STEM major with a minimum of 5 years of Information Systems experience OR Bachelor s degree in computer science or STEM major with a minimum of 7 years of Information Systems experience. Must-Have Skills: Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Thorough understanding of modern web application development and delivery, Gen AI applications development, data integration and enterprise data fabric concepts, methodologies, and technologies (e.g. AWS technologies, Databricks) Prior hands-on experience with full-stack development, including back-end web and APIs using infrastructure cloud services (AWS preferred) and cloud-native tools and design patterns (Containers, Serverless, Docker, etc). Demonstrated experience in navigating matrix organization and leading change. Define success metrics for developer productivity metrics; on a monthly/quarterly basis analyze how the product team is performing against established KPI s. Preferred Qualifications: Strong influencing skills, influence stakeholders and be able to balance priorities Prior experience in vendor management Prior experience in biotechnology or pharma industry Professional Certifications: AWS Certified Solutions Architect (preferred) Certified DevOps Engineer (preferred) Certified Agile Leader or similar (preferred) Soft Skills: Strong desire for continuous learning to pick new tools/technologies. High attention to detail is essential with critical thinking ability Should be an active contributor to technological communities/forums Proactively engages with cross-functional teams to resolve issues and design solutions using critical thinking and analysis skills and best practices. Influences and energizes others toward the common vision and goal. Maintains excitement for a process and drives to new directions of meeting the goal even when odds and setbacks render one path impassable Established habit of proactive thinking and behavior and the desire and ability to self-start/learn and apply new technologies Excellent organizational and time-management skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Equal opportunity statement

Let s do this. Let s change the world. The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor s degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience. Master s degree and 4 to 6 years of experience. Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organizational change. The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor s degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience. Master s degree and 4 to 6 years of experience. Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Job Description We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Edit check development and Custom function programing Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experience Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) .

Let s do this. Let s change the world. The role is responsible for leading and charting the course for the MuleSoft Platform team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. The ideal candidate will have a consistent record of leadership in technology-driven environments for the MuleSoft or Enterprise Integration area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Understand the decision-making process, workflows, and business and information needs of business partners and team members Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an issue point and facilitating communication when service commitments are not met Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree/Masters degree/Bachelor s degree with 8- 13 years of experience in Computer Science, IT or related field. Functional Skills: Must-Have Skills: Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Exposure to or basic understanding of MuleSoft Anypoint Platform or similar integration tools Experience with Java, SQL Knowledge of cloud platforms (e.g., AWS, Azure) or container technologies (Docker) Professional Certifications (please mention if the certification is preferred or mandatory for the role): Scaled Agile Framework (SAFe) for Teams (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will have a proven track record of leadership in technology-driven environments using 3DEXPERIENCE Cloud SaaS platform and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage diverse team within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for handling, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate best practice sharing, ensuring ongoing alignment with the Technology & Digital strategy Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills: Strategize, plan, and implement various phases of PLM roadmap with a clear focus on eliminating manual workflows, streamlined process, and enabling digital thread using Dassault Systemes 3DEXPERIENCE platform and integrating with key enterprise platforms Strong Technical/Functional experience solutioning and supporting GMP applications across Engineering, Clinical, Commercial and Quality functions. Demonstrated hands-on experience in managing technology solutions involving ENOVIA, DELMIA, CATIA Report Generator, NETVIBES, EKL, and OTScript in a SaaS environment. Strong hand-on experience with configuring and customizing solutions for Requirements, CAD, EBOM, MBOM, Configuration/Variants, Recipe, MPP, Risk, Document and Change management. Must have led multiple data migration from various sources to 3DEXPERIENCE platforms. Must have experience in creating solutions using Enterprise Integration Framework to integrate with enterprise systems such as Enterprise Data Fabric, Veeva vault, SAP, MES systems. Must be familiar with middleware systems such as Mulesoft, Boomi or Tibco. Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively manage collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies using Scaled Agile (SAFe). Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business stakeholders Broad working knowledge of key IS domains and layers Professional Certifications: Scaled Agile Framework (SAFe) for Teams (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The role is responsible for managing the R&D Veeva Vault Platform technical team that develops and implements technology strategies, solutions, and services to support Amgen s Veeva Vault Platform. The role will be involved in defining Amgen s Veeva Vault Platform strategy, guiding technology decisions, and ensuring that all implementations adhere to established architectural principles, Veeva s and the Industry s standard processes. The ideal candidate will have a consistent track record of leadership in technology-driven environments, managing technology platforms, digital transformation initiatives, and have a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Develop and maintain the enterprise Veeva Vault Platform architecture vision and strategy, ensuring alignment with business objectives Responsible for fostering platform reliability and efficiency through streamlined release management & execution and establishing consistent DevOps & CI/CD framework Accountable for designing and building customizations & configurations on the Platform as per the business needs including, creating custom objects, fields, workflows and SDKs Responsible for strategizing Platform Integrations while adhering to consistent integration standards and patterns, designing integration workflows, building connectors, centralizing build & run and performing consistent DevOps model for integrations Identify and mitigate architectural risks, ensuring that the platform is scalable, secure, and resilient Maintain comprehensive documentation of the platform architecture, including principles, standards, user guides, and models Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs Perform impact assessments, clearly define AS-IS and TO-BE states, and recommend platform upgrades in accordance with the new features and functionalities released by Veeva Design platform architecture that can scale to meet growing business needs and performance demands Develop and maintain logical, physical, and conceptual data models to support business needs Establish and enforce data standards, governance policies, and best practices What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Master s degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field Must-Have Skills: Solid understanding of Veeva Vault Platform and Veeva Vaults 6-8 years Global Pharmaceutical experience Have Team\People management experience Experience with system integration technologies like Mulesoft, Databricks, etc. Excellent knowledge of data model and governance Solid understanding of pharmaceutical operations and data management business processes Experienced in pharmaceutical regulations and specifications Experienced in GxP process Experience working in agile methodology, including Product Teams and Product Development models Proficiency in designing scalable, secure, and cost-effective solutions Can work late hours Can work with multiple teams to meet the business and collaborator needs Can lead and guide multiple teams to meet business needs and goals Have collaborator and team management skills Good-to-Have Skills: Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications: Veeva Vault Platform Administrator (mandatory) SAFe - DevOps Practitioner (mandatory) SAFe for teams (preferred) Soft Skills: Should be able convert business requirements into technical requirements Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Manager Quality Complaints supervises a team of complaint investigators owning records with basic investigations, customer feedback records and records with limited information. Quality Manager Complaints ensures execution of the complaint process in compliance with company policies/procedures and regulatory requirements. Ensures execution of the quality complaint process in compliance with the applicable procedures, laws and regulations Ensures quality of tasks and complaint records Leads team initiatives/projects Establishes performance expectations and monitors for daily improvement Prioritizes workload as needed based on the changing incoming volumes or records Leads and mentors a team of complaint investigators, providing mentorship and support as needed Raises potential quality issues to management Monitors teams performance and oversight of staffs performance and development Assures training is continuously maintained Accountable for day-to-day operations of the staff members under their supervision Participates in audits and assessments as required, providing documentation and information on complaint management processes Develops a culture of continuous improvement and customer-centricity within the team What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of quality management, with focus on complaints handling experience OR Bachelor s degree and 6 to 8 years of quality management, with focus on complaints handling experience OR Diploma and 10 to 12 years of quality management, with focus on complaints handling experience Preferred Qualifications: Quality and manufacturing experience in biotech, medical device or pharmaceutical industry Leadership skills and the ability to supervise multiple projects simultaneously Familiarity with advance project management tools Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience in driving decision making by using DAI principles Understanding of quality and industry requirements/expectations of a QMS Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Ability to negotiate a strategic position after taking feedback from multiple sources Proven ability to lead cross-functional teams, consistently deliver timely, and high-quality results Build rapport with customers and colleagues to develop a collaborative environment. Ability to handling disagreements and finding resolutions that satisfy both parties. Adjust strategies and approaches based on the specifics of each complaint. Ability to work optimally with global, virtual teams. Grasp reputability and steering through regulatory guidelines and compliance obligations. View issues from the customers perspective to better understand their concerns. Ability to travel +/- 20% of time to domestic and international Amgen sites Note: This role may require working in shifts or extended hours within the same shift What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.