Sr. GxP Product Manager

Overview

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.

Position 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 role blends Product Manager responsibilities with GxP Business Analyst skillsets to deliver validated, compliant, and impactful lab informatics solutions which drive user adoption and ongoing business value, responding to the ongoing needs of 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 with teams across regulatory operations, clinical, and other business units to maximize the value of our digital platforms. You will bring deep product expertise in Laboratory Information Management Systems (LIMS), E2E data pipeline solutions, GxP reporting/data visualizations, and GxP-compliant environments.

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 with business stakeholders and users across Analytical Development, Quality, QA, and business operations to align processes and functions with our overarching digital strategy, while ensuring a strong user experience that is compliant and maintains operational excellence.

• Defining user stories, acceptance criteria, and functional scope for features that capture business requirements and expected outcomes.
• Serve as a liaison between technical teams and business users to elicit and document detailed business, functional, and data requirements in collaboration with end users.
• Align on success criteria and post-launch KPIs.
• Prioritize the backlog and sprint work items based on time, DoR criteria, resources, and business value.
• Act as the go-to expert for product capabilities, integrations, and compliance impacts.
• Lead backlog refinement, manage sprint planning, and define priority features against DoR standards and acceptance criteria.
• Ensure delivery through adaptive agile product management practices aligned to GxP standards and DoD criteria.
• Translate complex technical requirements into clear, business-friendly narratives using writing, 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 requirements.
• Contribute to Computer System Validation (CSV) efforts, including authoring or reviewing validation documentation (URS, FRS, IQ/OQ/PQ, test protocols).
• Contribute to business case development and ROI to drive measurable value.
• Measure and report product and project status to stakeholders and senior leadership.
• Experience working 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 operational metrics and generating reports.
• Contribute to short- and long-term roadmaps that deliver value and support Moderna’s digital vision.
• Oversee application lifecycle and release management to maintain compliance and GxP requirements including 21 CFR Part 11, Annex 11, and ALCOA+ principles.

• Minimum 7+ years of experience in GxP biotech/pharma space.
• Minimum 5+ years as a Product Owner/Product Manager in digital healthcare/biotech/pharma with experience delivering end-to-end data solutions and GxP reporting;
  Spotfire and Tableau experience highly desired.
• Minimum 5+ years as a GxP Business Analyst specializing in LIMS in biotech or pharma;
  Labvantage 8.7 experience highly desired.
• Minimum 3+ years hands-on…