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 workstreams 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. Responsibilities 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. Basic Qualifications 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 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. Expertise with tools: JIRA for backlog management and sprint planning; Confluence for requirements and documentation; Validation documentation and SDLC processes. Strong proficiency with Excel, PowerPoint. Preferred Qualifications A data-driven systems thinker who understands interdependencies across platforms and processes and how they affect enterprise data strategies. Team player who asks critical questions to identify root causes. Understanding that a strong user experience drives launch and adoption. Excellent communication and storytelling with the ability to align scope across global teams. Strong collaboration and relationship-building skills with stakeholders and delivery teams. Ability to translate between business, product, technical, and data audiences. Ability to manage conflicting priorities and thrive in a fast-paced environment. Excellent time management and ability to handle multiple responsibilities. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. Our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs. Holistic well-being resources including 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. Location-specific perks and extras. Salary range: $145,900.00 - $234,200.00. Actual pay depends on factors including competencies, education, experience, and performance. Eligible for discretionary bonus, incentive compensation, or equity, subject to company plan and individual performance. About Moderna Since 2010, Moderna has aspired to build the leading mRNA technology platform and a world-class team. We aim to empower our people with a platform to change medicine and the world. We are committed to belonging, patient care, our people, the environment, and communities. Moderna has been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. Our Working Model Moderna supports an in-person culture with a 70/30 in-office model. We value collaboration, mentorship, and innovation. Moderna is a smoke-free, alcohol-free, and drug-free workplace. Equal Opportunities Moderna is an equal employment opportunity employer. We do not discriminate on race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other protected characteristic. Applicants who meet the Basic Qualifications are encouraged to apply. Moderna is an E-Verify Employer in the United States and may require suitability checks. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations Moderna offers reasonable accommodations to qualified job applicants with disabilities. To request accommodations during hiring, contact View email address on click.appcast.io. Export Control Notice: This position may involve access to export-controlled technology or data. Employment is contingent on ability to access export-controlled information in accordance with U.S. law. Only U.S. persons are eligible for this position. Moderna cannot sponsor non-U.S. persons for export control purposes. #J-18808-Ljbffr BioSpace