Sr. GxP Product Manager

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 which drive user adoption, ongoing business value and respond to the ongoing needs of our users around the world. 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.

• Defining user stories, clear acceptance criteria, and precise functional scope for agreed‑upon features which capture business requirements and expected outcomes.
• Serve as a liaison between technical teams and business users to ensure mutual understanding and shared expectations by partnering with stakeholders to elicit and document detailed business, functional, and data requirements.
• Align on what defines success and how we will measure success post‑launch with clear KPIs.
• Ruthlessly prioritize the backlog and sprint work items 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, define and prioritize product features and scope against DoR standards and clear acceptance criteria.
• Ensure successful delivery through adaptive agile product management practices that align to GxP standards and meet Definition of Done (DoD) criteria.
• Translate complex technical requirements to drive alignment and decision‑making, including data dependencies, into clear, business‑friendly narratives through writing, verbal presentations or slides.
• Align with business stakeholders on data governance and operational process needs.
• Lead or contribute to impact assessments, evaluating how process changes affect system behavior/requirements and articulating key outcomes back 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 analysis to drive measurable value.
• Measure and report product and project status to a variety of audiences, including stakeholders and senior leadership.
• Work 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, tracking metrics and generating reports.
• Contribute to the creation of short‑ and long‑term roadmaps delivering value, driving efficiencies, and supporting Moderna’s bold digital vision.
• Oversee application lifecycle and release management activities, ensuring product configurations maintain compliance and that all systems meet GxP requirements, including 21
  
  CFRPart
  11, Annex
  11, and ALCOA+ principles.

• Minimum 7+ years experience in GxP biotech/pharma space.
• Minimum 5+ years as a Product Owner/Manager in digital healthcare/biotech/pharma space with strong experience delivering end‑to‑end data solutions and GxP reporting outcomes.
• Spotfire and Tableau experience highly desired.
• Minimum 5+ years as a GxP Business Analyst specializing in LIMS systems.
• Labvantage
  8.7 experience highly desired.
• Minimum 3+ years of hands‑on experience with GxP LIMS systems.
• Strong experience in data life cycles and data governance procedures.
• Strong understanding of stability testing procedures, data and regulatory requirements to maintain stability…