GxP Product Manager

Moderna

2d • Hybrid

About The Position

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. This is a rare opportunity to join Moderna’s Digital team as a key player in the development and lifecycle management of lab informatics platforms that directly impact global regulatory and clinical operations. Blending the strategic lens of a product manager with the precision of a GxP business analyst, this high-visibility role is central to building validated, compliant, and business-critical applications. You will work hands-on with Laboratory Information Management Systems (LIMS), data pipeline integrations, and regulatory reporting platforms to deliver user-centric solutions that scale with Moderna’s scientific ambitions. You will lead multiple workstreams covering UX, architecture, integration, and validation, while collaborating across Analytical Development, Quality, QA, and business operations. You'll serve as the go-to expert for product capabilities, integration logic, data governance, and operational excellence. The role offers a front-row seat to digital transformation and proximity to next-gen technologies such as Generative AI tools that are beginning to shape the future of biopharma data landscapes.

Requirements

• The ideal candidate will have strong GxP Business Analyst skills and experience who made a successful transition to a Product Management role.
• 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.
• Spotfire and Tableau experience highly desired.
• Minimum of 5+ years as GxP Business Analyst specializing in LIMS systems in biotech or pharma space.
• Labvantage 8.7 experience highly desired.
• 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

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees