Job
Description
What you will do In this vital role You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. Role Description: In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, developers, test/validation engineers, project managers and scrum masters responsible for the ongoing design, development, management, and optimization of Amgens digital products enabling the regulatory submission content automation initiative. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources. The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires deep expertise in handling the end-to-end development and delivery of customer-facing digital product capabilities and platforms including generative AI, structured content management. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with 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, technical product ownership, business analysis, be 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 to ensure all collaborators feel informed and engaged Oversee the software development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams Lead and handle large, teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership Ensuring global ways of working are embedded in the local organization Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation Fostering standard methodology sharing and alignment with business goals Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion 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: Masters degree with 10 - 12 years of experience in Engineering, IT or related field OR Bachelors degree with 12 - 14 years of experience in Engineering, IT or related field Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. Proven experience working with large-scale data environments comprising data pipelines, and enterprise cloud solutions. In-depth knowledge of data engineering concepts, ETL processes, and data architecture principles. Strong understanding of cloud computing principles, particularly within the AWS ecosystem Working knowledge of 21 CFR, ISO 13485 and experience working in regulatory environments Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5-8 years of domain knowledge in health and/or life sciences combined with Information Technology Proficiency in Python/PySpark development, Fast API, PostgreSQL, Databricks, DevOps Tools, CI/CD, GitLab, and Data Ingestion. Understanding, and preferably applied experience and knowledge, in data management and CTD document drafting Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Understanding of ITIL processes and implementation. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. 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 Strong presentation and public speaking skills.
