3 Gxp Process Jobs

In this vital role, you will be responsible for leading the team to support and maintain the Amgen Veeva Vault Platform. This position involves defining Amgen's Veeva Vault Platform support strategy, guiding technology decisions, and ensuring timely service delivery to platform users, including resolving their issues. The ideal candidate will have a consistent record of leadership in technology-driven environments, leading technology platforms and digital transformation initiatives, and a passion for fostering innovation and excellence in the biotechnology industry. Collaboration with cross-functional and global teams is essential to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational initiatives, develop a collaborative environment, and achieve high-quality results within a matrixed organizational structure. Roles & Responsibilities Develop and maintain the enterprise Veeva Vault Platform support strategy, ensuring alignment with business objectives. Responsible for fostering platform reliability. Identify and mitigate architectural risks, ensuring that the platform is scalable, secure, and resilient. Maintain knowledge base of Veeva issues, including principles, standards, user guides, and models. Drive continuous improvement in the architecture by identifying opportunities for innovation and efficiency. Work with stakeholders to gather and analyze requirements, ensuring that solutions meet both business and technical needs. Accountable for designing and building customizations & configurations on the Platform as per 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 implementing a consistent DevOps model for integrations. Perform impact assessments, clearly define AS-IS and TO-BE states, and recommend platform upgrades in accordance with 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 implement 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. Basic Qualifications Master's degree with 4 - 6 years of experience in Computer Science, IT, or a related field; OR Bachelor's degree with 6 - 8 years of experience in Computer Science, IT, or a related field; OR Diploma with 10 - 12 years of experience in Computer Science, IT, or a related field. Functional Skills Must-Have Skills Solid understanding of Veeva Vault Platform and Veeva Vaults. Experience with system integration technologies like Mulesoft, Databricks, etc. Excellent knowledge of data model and governance. 6-8 years of global pharmaceutical industry experience. Solid understanding of pharmaceutical operations and data management business processes. Experienced in pharmaceutical regulations and specifications. Have Team/People management experience. Experienced in GxP processes. Experience working in Agile methodology, including Product Teams and Product Development models. Proficiency in designing scalable, secure, and cost-effective solutions. Ability to work late hours. Ability to work with multiple teams to meet business and stakeholder needs. Ability to lead and guide multiple teams to meet business needs and goals. Have stakeholder 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 Ability to convert business requirements into technical requirements. Excellent critical-thinking and problem-solving skills. Good communication and collaboration skills. Proven awareness of how to function in a team setting. Proven 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.

Manager, Information Systems Veeva Service Delivery What you will do In this vital role you will responsible for leading the team to support and maintain the Amgen Veeva Vault Platform. The role will be involved in defining Amgens Veeva Vault Platform support strategy, guiding technology decisions, and ensuring timely service is deliver to the Amgen Veeva Vault platform users and their issues are resolved. The ideal candidate will have a consistent record of leadership in technology-driven environments, leading 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, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Develop and maintain the enterprise Veeva Vault Platform support strategy, ensuring alignment with business objectives. Responsible for fostering platform reliability. Identify and mitigate architectural risks, ensuring that the platform is scalable, secure, and resilient Maintain knowledge base of Veeva issues, including principles, standards, user guides, and models Drive continuous improvement in the architecture by seeing opportunities for innovation and efficiency Work with collaborators to gather and analyze requirements, ensuring that solutions meet both business and technical needs 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 implementing consistent DevOps model for integrations 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 implement 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. Basic Qualifications: Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelors 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 Experience with system integration technologies like Mulesoft, Databricks, etc. Excellent knowledge of data model and governance 6-8 years Global Pharmaceutical experience Solid understanding of pharmaceutical operations and data management business processes Experienced in pharmaceutical regulations and specifications Have Team\People management experience 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 Proven awareness of how to function in a team setting Proven 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 will do The Veeva Vault Release Manager will spearhead Veeva change and release management initiatives within Amgens Veeva Vault ecosystem. This role focuses primarily on change and release management, encompassing the planning, scheduling, and deployment of changes and releases across various Veeva Vault in Amgen. As the key point of contact, you will provide essential support and expertise to business key users. Roles & Responsibilities : Develop and implement the release management process for Amgen Veeva Vault paltform. Publish integrated release calendar; manage cut-over and rollback. Manage release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to facilitate smooth and efficient Veeva releases. Assess and plan for the impact of Veeva changes and releases on collaborators. Develop and manage communication plans to engage Veeva collaborators and provide clear messaging. Identify and involve key collaborators and leaders, facilitating workshops and training to support change. Design and deliver training programs, offering ongoing support and coaching. Evaluate the impact of changes, address risks and resistance, and track the effectiveness of change efforts. Maintain documentation, prepare reports for senior management, and implement the best practices. Oversee planning, scheduling, and coordination of Veeva releases, ensuring alignment with change management strategies. Lead talent engagement and team-building activities to foster a positive work environment. Organize and manage internal communications, including monthly newsletters, to keep the collaborator informed and engaged. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 8 - 10 years of experience in Business, Engineering, IT or related field OR Bachelors degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field Strong understanding of Veevas Vault and its modules applications. Proven ability to develop and implement change management strategies and communication plans. Strong experience in collaborator engagement, training, and change impact assessment. Experience in managing the release management lifecycle, including scheduling and coordination. 6-8 year Global Pharmaceutical experience. Team\People management experience. 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. Excellent written and verbal communication skills Preferred Qualifications: Familiarity with Agile methodologies for change management. Experience with change management tools and software. Knowledge of industry-specific regulations and standard methodologies, particularly in Life Sciences or Pharmaceuticals. Strong solution design and problem-solving skills Strong understanding of technology, function, or platform 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 Strong 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.