Manager, GxP Systems

Manager, GxP Systems

In this role, you will be responsible for delivering validation, qualification, and testing activities across Moderna’s Digital landscape, including CMC, Digital for Development, Enterprise Platforms, Data Platforms, and Infrastructure. You will apply Computer Software Assurance (CSA) principles and risk-based approaches to plan, develop, execute, review, and approve validation and testing deliverables that ensure GxP applications and infrastructure are appropriately validated and qualified throughout their lifecycle.

You will provide hands-on validation and testing leadership while directing and overseeing contractors and delivery partners to ensure deliverables are completed with the appropriate quality, rigor, and efficiency. You will partner with Digital teams, Compliance, Quality, and system owners while leveraging AI, automation, and modern testing approaches to accelerate delivery, and help define and continuously improve the processes, methodologies, and tools used to validate and qualify applications and infrastructure.

Here’s What You’ll Do

• Partner with Digital teams, Compliance, Quality, system owners, business process owners, and implementation partners to define validation requirements, resolve issues, and enable timely delivery of GxP technology.
• Own and deliver validation, qualification, and testing activities for GxP applications, platforms, data solutions, and infrastructure across Moderna’s Digital landscape.
• Develop and execute risk-based validation, qualification, and testing strategies using Computer Software Assurance (CSA) principles and applicable regulatory requirements.
• Author, review, and approve key validation deliverables, including GxP applicability and data integrity assessments, validation plans, risk assessments, requirements, test strategies/scripts, traceability, deviations, and validation reports.
• Lead the planning, execution, and documentation of testing, ensuring the level of assurance is appropriate for system intended use, complexity, and GxP risk.
• Support the validation and assurance of AI-enabled GxP applications, applying risk-based controls and testing approaches appropriate to their intended use.
• Apply CSA principles and leverage supplier evidence, automation, AI, and modern testing approaches to increase validation efficiency while maintaining appropriate GxP assurance.
• In partnership with Digital, Compliance, and Quality colleagues, define and continuously improve the processes, methodologies, templates, and tools used to validate, qualify, and test GxP applications and infrastructure while supporting audit and inspection readiness.
• Provide technical direction and oversight to contractors, consultants, and delivery partners performing validation, qualification, and testing activities, ensuring deliverables meet Moderna quality and compliance expectations.
• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, Information Systems, or a related discipline, with 6+ years of relevant experience in the pharmaceutical, biotechnology, medical device, or other regulated industry; or a Master’s degree with 4+ years of relevant experience.
• 4+ years of hands-on experience with GxP computerized systems, including validation, testing, digital quality, or compliance activities.
• Demonstrated experience with Computer Software Assurance (CSA), including risk-based assurance, critical thinking, appropriate use of scripted and unscripted testing, and leveraging supplier evidence.
• Strong knowledge of applicable regulatory requirements and industry guidance, including 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, and risk-based validation and assurance approaches.
• Experience developing, reviewing, and/or approving validation and testing deliverables, including GxP applicability assessments, data integrity assessments, validation plans, risk assessments, requirements, test strategies and scripts, traceability, deviations, and validation reports.
• Experience with SaaS/cloud-based GxP applications and evaluating and leveraging supplier/vendor documentation and testing evidence.
• Working knowledge of SDLC, change management, and release management processes and their application to regulated computerized systems.
• Demonstrated experience leading and overseeing contractors, consultants, or external service providers, including assigning work, reviewing deliverables, providing technical direction, and ensuring work meets quality, compliance, and delivery expectations.
• Demonstrated ability to lead cross-functional validation and testing activities and influence without direct authority, partnering effectively with Quality, Digital/IT, business process owners, system owners, vendors, and implementation partners.
• Strong written and verbal communication skills, including the ability to translate regulatory and quality requirements into pragmatic system, assurance, and testing requirements.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Experience validating or assuring artificial intelligence (AI), machine learning (ML), or AI-enabled applications in a GxP environment, including applying risk-based approaches to intended use, data, model performance, testing, human oversight, and ongoing system changes.
• Experience leveraging AI, automation, or digital tools to improve or accelerate validation and testing activities, such as requirements development, risk assessments, test generation, test execution, traceability, or documentation review.
• Experience developing or improving validation, qualification, and testing methodologies, processes, templates, and tools to increase efficiency while maintaining appropriate GxP compliance and control.
• Experience validating or qualifying solutions across multiple technology domains, such as enterprise applications, data platforms, cloud infrastructure, laboratory/manufacturing systems, or development platforms.
• Demonstrated ability to identify opportunities to simplify and modernize traditional validation approaches through risk-based assurance, automation, supplier leveraging, and new technologies.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Pay & Benefits

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

• Competitive healthcare, 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 building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• 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.

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.

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 committed to equal opportunity in employment 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