GxP Product Manager

Serve as product owner for critical lab informatics platforms (GxP-compliant LIMS, visualization/reporting tools).,Lead development and refinement of user stories and functional scope based on business needs and KPIs.,Drive sprint planning and backlog prioritization using agile methods in validated system environments.,Collaborate with business stakeholders (regulatory, clinical, QA) for alignment and value delivery.,Translate complex system architectures and data flows into business narratives.,Lead application lifecycle and release management processes, ensuring compliance with global regulatory standards (21 CFR Part 11, Annex 11, ALCOA+).,Partner with engineering and validation teams for computer system validation (CSV) deliverables, including authoring test protocols and user requirements.,Define success criteria and track measurable ROI of implemented solutions.,Manage offshore and global teams, and vendor partners in regulated settings.,Maintain and govern digital platforms for operational excellence and scalability.,Author or contribute to impact assessments and validation deliverables (URS, FRS, IQ/OQ/PQ).,Act as SME for platform integrations, user experience standards, and compliance impacts.,Contribute to short- and long-term product roadmaps.,Establish and maintain operational metrics and generate reports.,Apply adaptive agile practices within a GxP environment.,Support data governance initiatives.,Participate in business case development.,Engage with Generative AI-enhanced solutions.

Highly-organized, data-driven systems thinker who understands interdependencies between multiple platforms, diverse processes, cross-functional teams and how these impact enterprise data strategies and outputs.,Team player who is unafraid to ask probing 'what-if' questions to get to the actual problem statement/root cause.,Understands the criticality of a strong user experience to drive launch and adoption.,Excellent communicator with strong active listening skills and storytelling abilities, an empathetic approach and ability to rapidly align clear scope across diverse cross-functional global team processes.,Strong collaboration and relationship-building skills with a diverse set of business stakeholders and technical delivery teams.,Knows when to dive into the deep details and when to pull back to provide a high-level view.,Proficient in business, product, technical and data languages, able to effortlessly translate between them based on audience.,Ability to manage conflicting priorities and thrive in a fast-paced, dynamic environment with shifting priorities.,Excellent time management skills and ability to swap between multiple hats in a fast-paced environment.,Strong GxP Business Analyst skills and experience who made a successful transition to a Product Management role.

Employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.,Moderna is unable to sponsor non-U.S. persons to apply for an export control license for this role.