Moderna · 1 month ago
GxP Product Manager
Cambridge, Massachusetts
Full-time
Onsite
Senior Level
$146K/yr - $234K/yr
7+ years expModerna is a pioneering company revolutionizing medicine through mRNA technology, and they are seeking a GxP Product Manager to join their Digital team. This role involves the development and lifecycle management of lab informatics platforms, ensuring compliance and delivering user-centric solutions that align with global health initiatives.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
Responsibilities
Serve as product owner for critical lab informatics platforms, particularly GxP-compliant LIMS and visualization/reporting tools
Lead the development and continual refinement of user stories and functional scope based on evolving business needs and KPIs
Drive sprint planning and backlog prioritization using agile methods tailored to validated system environments
Collaborate with business stakeholders across regulatory, clinical, and QA to ensure alignment and maximize value delivery
Translate complex system architectures and data flows into business-friendly narratives for decision-making and alignment
Lead application lifecycle and release management processes to ensure compliance with global regulatory standards (21 CFR Part 11, Annex 11, ALCOA+)
Partner with engineering and validation teams to execute 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, as well as vendor partners in regulated settings
Maintain and govern digital platforms across their lifecycle to support operational excellence and system 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 across digital tools
Contribute to both short- and long-term product roadmaps aligned with Moderna’s digital and clinical strategies
Establish and maintain operational metrics and generate reports for senior leadership
Apply adaptive agile practices within a GxP environment to ensure rigorous but flexible product delivery
Support data governance initiatives in collaboration with business stakeholders
Participate in business case development with measurable ROI and value frameworks
Engage with Generative AI-enhanced solutions to further optimize platform performance and insight generation
Qualification
Required
Minimum 7+ years experience in GxP biotech/pharma space
Minimum of 5+ years as a Product Owner/Product Manager in digital healthcare/biotech/pharma space with strong experience in delivering E2E data solutions and GxP reporting outcomes
Minimum of 5+ years as GxP Business Analyst specializing in LIMS systems in biotech or pharma space
Minimum of 3+ years of hands-on experience with GxP LIMS systems
Strong experience in data lifecycles and data governance procedures
Strong understanding of stability testing procedures, data and regulatory requirements to maintain stability testing compliance
Expert in following tools and areas: JIRA for backlog management, refinement and sprint planning, Confluence for version-controlled functional requirements and other key product documentation, Validation documentation and SDLC processes
Strong proficiency in the following tools and areas: Excel, PowerPoint, Kneat
Preferred
Spotfire and Tableau experience highly desired
Labvantage 8.7 experience highly desired
Benefits
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-02-03
2026-02-02
Company data provided by crunchbase