Principal GxP Product Manager

The Role 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. Here's What You’ll Do Your key responsibilities will be: 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. Your responsibilities will also include: 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. The key Moderna Mindsets you’ll need to succeed in the role: “We digitize everywhere possible using the power of code to maximize our impact on patients.” This role is at the core of that mindset. You will own and shape digital platforms that translate lab, quality, and regulatory requirements into powerful, compliant tools that drive Moderna’s mission forward. You’ll lead the charge in integrating intelligent digital solutions and begin to explore Generative AI's potential for unlocking faster, smarter insights. “We behave like owners. The solutions we’re building go beyond any job description.” As the sole product lead for multiple mission-critical digital applications, you won’t just deliver what’s asked—you’ll anticipate user needs, optimize system behaviors, and influence long-term strategy. This is a hands-on role where ownership, initiative, and accountability are the keys to success. Who We Are A highly-organized, data-driven systems thinker who understands the 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 the hard “what-if” questions (in the appropriate tone and forums) to probe on symptoms in order to get to the actual problem statement/root cause of what we are solving for You understand 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 You know when to dive into the deep details and when to pull back to provide a high-level view You speak these languages well and can effortlessly translate between them based on your audience: business, product, technical and data 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. You love having many hats…and know which one to wear when Here’s What You’ll Need (Basic Qualifications) 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 Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why 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 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 The salary range for this role is $158,600.00 - $285,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.   By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.  We are proud to have 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.  If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.  Our Working Model  As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.  Moderna is a smoke-free, alcohol-free, and drug-free work environment.  Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.  Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.  Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.  Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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