Senior GXP Product Owner

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.

Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

We are seeking a highly skilled and versatile Senior GxP Product Owner with deep expertise in Laboratory Information Management Systems (LIMS) and GxP-compliant environments. This Warsaw-based role is both strategic and executional — blending traditional Product Owner capabilities with GxP Business Analyst expertise. You will serve as one of the key product voices for our global LIMS system and play a critical role in shaping its vision, roadmap, and delivery. Through adaptive agile practices, robust compliance, and close collaboration across global Quality, QA, lab users, and business operations, you will deliver validated, impactful lab informatics solutions that drive measurable business value. This position will expose you to GenAI-aligned digital strategies, enterprise data ecosystems, and next-generation informatics architectures, positioning you at the frontier of life sciences and emerging technology.

Here’s What You’ll Do

Your key responsibilities will be:

• Own and continuously prioritize the LIMS product backlog in alignment with business value, regulatory demands, and systems architecture.
• Act as the product expert for capabilities, integrations, data dependencies, and compliance implications.
• Author, maintain, and deliver documentation such as Product Requirements Documents (PRDs), Business Requirements Documents (BRDs), and User Requirements Specifications (URS).
• Lead backlog refinement and sprint planning in collaboration with global technical and delivery teams, ensuring adherence to Definition of Ready and acceptance criteria.
• Facilitate alignment between business and technical stakeholders through clear, business-oriented translations of complex technical requirements.
• Ensure Computer System Validation (CSV) rigor, including documentation and execution of URS, IQ/OQ/PQ, and test protocols.
• Champion compliance with GxP standards including 21 CFR Part 11, Annex 11, and ALCOA+.
• Define key performance indicators (KPIs) in partnership with business teams to measure post-launch impact and success.
• Partner with QA to ensure audit readiness and continuous compliance.
• Deliver business case contributions to support ROI narratives and strategic technology investments.

Your responsibilities will also include:

• Acting as a cross-functional bridge to elicit and document functional, data, and process requirements globally.
• Supporting impact assessments for new features and process modifications, and clearly communicating system behavior changes.
• Translating complex concepts into digestible formats (slides, presentations, or reports) for various stakeholders, including senior leadership.
• Navigating multi-platform interdependencies and data strategies that support global operations and scalable compliance.
• Managing multiple workstreams and roles fluidly, wearing “multiple hats” and switching context effortlessly in a fast-paced setting.
• Collaborating with globally distributed teams, including offshore delivery partners, ensuring clear direction and shared understanding.
• Contributing to ongoing evolution of our platform capabilities in ways that connect to Generative AI integrations and future-state data automation.

The key Moderna Mindsets you’ll need to succeed in the role:

• “We obsess over learning. We don’t have to be the smartest — we have to learn the fastest.” You will constantly be synthesizing technical, regulatory, and business feedback to evolve a complex, validated system while ensuring readiness for innovation — including GenAI use cases.
• “We behave like owners. The solutions we’re building go beyond any job description.” This role is not limited to backlog grooming or requirements gathering — you’ll serve as a cross-functional product thought partner, technical translator, and compliance advocate with autonomy and accountability at the core.

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.

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.

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

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!

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

Here’s What You’ll Need

The ideal candidate will have strong GxP Business Analyst skills and experience who made a successful transition to a Product Owner role.

• Minimum 7+ years experience in GxP biotech/pharma space
• Minimum of 5+ years as a Product Owner in digital healthcare/biotech/pharma space
• 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, inclusive of master data
• Expert in following tools and areas:
  • JIRA and Confluence for backlog management, refinement and sprint planning
  • Validation documentation and SDLC processes
• Strong proficiency in the following tools and areas
  • Excel, PowerPoint