Sr. GxP Product Manager

About 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 that drive user adoption, ongoing business value, and respond to the needs of our 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 closely with teams across regulatory operations, clinical, and other business units to maximize the value of our digital platforms. As the day‑to‑day product manager on this high‑visibility initiative, you will manage multiple workstreams, including UX, architecture, configuration, integration, and system validation. You will collaborate closely with business stakeholders and users across Analytical Development, Quality, QA and business operations, align processes, and, together with engineering and validation teams, implement technical solutions that align with our overarching digital strategy while ensuring a strong user experience that is compliant and maintains operational excellence. Responsibilities Defining user stories, clear acceptance criteria, and precise functional scope for agreed‑upon features that capture business requirements and expected outcomes. Serve as a liaison between technical teams and business users to ensure mutual understanding and shared expectations, partnering with stakeholders to elicit and document detailed business, functional, and data requirements. Align on what defines success and how we will measure it post‑launch with clear KPIs. Ruthlessly prioritize the backlog and sprint work 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 in collaboration with delivery teams, and prioritize product features against DoR standards and clear acceptance criteria. Ensure successful delivery through adaptive agile product management practices that meet GxP standards and Definition of Done (DoD) criteria. Translate complex technical requirements into business‑friendly narratives through documentation, verbal 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 articulate key outcomes 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 impact to drive measurable value. Measure and report on product and project status to stakeholders and senior leadership. Collaborate 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 metrics and generating reports. Create short‑ and long‑term roadmaps that deliver value, drive efficiencies, and support Moderna’s digital vision. Oversee application lifecycle and release management activities, ensuring product configurations comply with 21 CFR Part 11, Annex 11, and ALCOA+ principles. Required Qualifications Minimum 7+ years of experience in the GxP biotech/pharma space. Minimum 5+ years as a Product Owner/Product Manager in digital healthcare/biotech/pharma, delivering end‑to‑end data solutions and GxP reporting outcomes. Experience with Spotfire and Tableau 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 with data lifecycles and data governance procedures. Strong understanding of stability testing procedures, data, and regulatory requirements to maintain compliance. Proficiency with JIRA for backlog management, refinement, and sprint planning. Proficiency with Confluence for version‑controlled product documentation. Experience with validation documentation and SDLC processes. Proficiency with Excel, PowerPoint, and Kneat. Preferred Qualifications Highly organized, data‑driven systems thinker who understands interdependencies among platforms, processes, and teams. Team player unafraid to ask probing questions to uncover root causes. Strong focus on user experience to drive launch and adoption. Excellent communicator with active listening, storytelling, and empathy. Strong collaboration and relationship‑building skills with diverse stakeholders and technical teams. Ability to balance detailed work and high‑level perspective. Ability to manage conflicting priorities in a fast‑paced environment. Exceptional time management skills and flexibility to wear multiple hats. Pay & Benefits Salary range: $145,900.00 - $234,200.00. Individual salary within the range based on competencies, qualifications, and experience. Potential eligibility for discretionary bonus, other incentive compensation, or equity award based on company plan eligibility. Best‑in‑class healthcare coverage and voluntary benefit programs. Holistic well‑being support, including fitness, mindfulness, and mental health resources. Family planning benefits: fertility, adoption, and surrogacy support. Generous paid time off, including vacation, volunteer days, sabbatical, and global recharge days. Savings and investment opportunities. Location‑specific perks and extras. Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military status, sexual orientation, marital or familial status, or any other characteristic protected under applicable law. We welcome applicants who meet the basic qualifications for the role. Accommodations We are committed to offering reasonable accommodations to qualified job applicants with disabilities. Contact the Accommodations team at View email address on click.appcast.io for assistance. Export Control Notice This position may involve access to technology or data subject to U.S. export control laws. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible. We cannot sponsor non‑U.S. persons for an export control license. Application Process To apply, visit modernatx.com/careers. We are an E‑Verify Employer in the United States and consider qualified applicants regardless of criminal histories, within legal requirements. #J-18808-Ljbffr Moderna