Manager, GxP Systems

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​.

As Manager, GxP Systems, you will be responsible for ensuring that all computer-based systems used within the organization are validated in compliance with regulatory standards and company policies. You will collaborate with key stakeholders across IT, Quality Assurance, and other departments to plan, execute, and maintain the validation lifecycle of computerized systems supporting product processing and quality control. This role requires a strong understanding of regulatory requirements such as 21 CFR Part 11 and Annex 11, as well as expertise in risk management principles related to computer system validation.

What You’ll Do:

Your key responsibilities will be:

• Develop and execute validation plans, test scripts, and validation reports for computerized systems, ensuring compliance with FDA regulations and industry best practices.

• Collaborate with IT and functional users to draft system requirements and design specifications for new systems or modifications to existing systems.

• Perform risk assessments on computer systems and apply risk management principles throughout the validation lifecycle.

• Maintain the validated state of systems through change control and periodic review processes.

• Ensure proper documentation and record-keeping for all validation activities in accordance with Good Documentation Practices (GDP).

• Create VP and VSR.

Your responsibilities will also include:

• Manage the validation documentation review/approval process.

• Stay current with regulatory guidelines and industry standards related to computer system validation, including 21 CFR Part 11 and Annex 11.

• Draft User Requirement Specifications (URS), User Acceptance Testing (UAT) scripts, and conduct dry runs while working closely with business teams on formal execution.

• Work with vendors and contractors to ensure externally developed systems meet validation requirements.

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

• We obsess over learning – The GxP landscape and regulatory frameworks are constantly evolving. Your ability to rapidly learn and adapt to new compliance requirements, validation methodologies, and digital tools will ensure our systems remain audit-ready and fully compliant​.

• We digitize everywhere possible – This role requires a deep understanding of digital systems supporting GxP functions. You will leverage digital validation processes and automation to enhance compliance, efficiency, and documentation management​.

What You’ll Need (Basic Qualifications):

• Bachelor’s degree in computer science, Information Technology, Engineering, Life Sciences, or a related field.

• Proven experience in computer system validation within a regulated environment, preferably in the pharmaceutical, biotech, or medical device industries.

• Strong understanding of FDA regulations, including 21 CFR Part 11, GAMP 5 guidelines, GCP/GLP and other relevant quality standards.

• Excellent analytical, organizational, and problem-solving skills.

• Ability to manage multiple projects and tasks in a fast-paced environment.

• Strong communication skills, both written and verbal, with the ability to clearly convey complex information to stakeholders at all levels.

• Proficient in the use of validation management software, preferably Kneat.

• Detail-oriented with a commitment to accuracy and quality.

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.

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! 

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, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

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 accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at [email protected]. 

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