GxP Product Manager

About the Role

At Moderna, we are revolutionizing modern healthcare by leveraging the power of digital technology to maximize our impact on patients’ lives. By joining us, you will have the unique opportunity to contribute to an organization making an unprecedented difference in society. As a Senior GxP Product Manager, Digital, you will lead system engineering initiatives and manage multiple digital platforms and applications that align with Moderna’s clinical and regulatory digital roadmap.

This dynamic role blends the Product Manager role with GxP Business Analyst skillsets and is key to delivering validated, compliant, and impactful lab informatics solutions that drive user adoption, ongoing business value, and respond to the needs of our users worldwide. Your role will be to ensure that these systems operate efficiently, reliably, and compliantly while remaining scalable to support our diverse portfolio.

You will collaborate closely with teams across regulatory operations, clinical, and other business units to maximize the value of our digital platforms.

As the day‑to‑day product manager on this high‑visibility initiative, you will manage multiple work streams, including UX, architecture, configuration, integration, and system validation. You will collaborate closely with business stakeholders and users across Analytical Development, Quality, QA and business operations, align processes, and, together with engineering and validation teams, implement technical solutions that align with our overarching digital strategy while ensuring a strong user experience that is compliant and maintains operational excellence.

• Defining user stories, clear acceptance criteria, and precise functional scope for agreed‑upon features that capture business requirements and expected outcomes.
• Serve as a liaison between technical teams and business users to ensure mutual understanding and shared expectations, partnering with stakeholders to elicit and document detailed business, functional, and data requirements.
• Align on what defines success and how we will measure it post‑launch with clear KPIs.
• Ruthlessly prioritize the backlog and sprint work based on time, definition of ready (DoR) criteria, resources, and business value.
• Act as the go‑to expert for product capabilities, integrations, and compliance impacts.
• Lead backlog refinement sessions, manage sprint planning in collaboration with delivery teams, and prioritize product features against DoR standards and clear acceptance criteria.
• Ensure successful delivery through adaptive agile product management practices that meet GxP standards and Definition of Done (DoD) criteria.
• Translate complex technical requirements into business‑friendly narratives through documentation, verbal presentations, slides, or a combination thereof.
• Align with stakeholders on data governance and operational process needs.
• Lead and/or contribute to impact assessments, evaluating how process changes affect system behavior and articulate key outcomes to stakeholders.
• Contribute to Computer System Validation (CSV) efforts, including authoring or reviewing validation documentation (URS, FRS, IQ/OQ/PQ, test protocols).
• Develop business case and ROI impact to drive measurable value.
• Measure and report on product and project status to stakeholders and senior leadership.
• Collaborate with globally distributed teams, including offshore delivery teams.
• Manage vendor partners in a regulated environment to ensure compliance and operational effectiveness.
• Prioritize, organize, and manage platform operations, including tracking metrics and generating reports.
• Create short‑ and long‑term roadmaps that deliver value, drive efficiencies, and support Moderna’s digital vision.
• Oversee application lifecycle and release management activities, ensuring product configurations comply with 21 CFR Part 11, Annex 11, and ALCOA+ principles.

• Minimum 7+ years of experience in the GxP biotech/pharma space.
• Minimum 5+ years as a Product Owner/Product Manager in digital healthcare/biotech/pharma, delivering end‑to‑end data solutions and GxP reporting outcomes.
• Experience with Spotfire and Tableau…