Manager, GxP Systems

Moderna Therapeutics; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family building benefits

Paid time off

Investment options

Location-specific perks

Job summary

Moderna Therapeutics in Warsaw seeks a senior validation lead to define validation requirements, deliver testing of GxP applications, and drive risk-based strategies across digital platforms and infrastructure. You will author, review, and approve validation deliverables, including data integrity assessments and test scripts, while partnering with Quality, Digital/IT, and vendors.

The role emphasizes CSA principles, supplier evidence, and automation to improve efficiency without compromising GxP

Qualifications

• 6+ years in pharmaceutical/regulated validation.
• Experience with CSA, risk-based testing, and supplier evidence.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity.

Responsibilities

• Define validation requirements and enable timely delivery of GxP technology.
• Own validation, qualification, and testing across applications, platforms, data solutions, and infrastructure.
• Lead planning, execution, and documentation of testing; ensure appropriate level of assurance for system use.

Skills

GxP validation

CSA knowledge

Regulatory compliance

Leadership

Testing strategy

Education

Bachelor's or higher in STEM

Tools

CSA tools

Job description

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 the 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 un‑scripted 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

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.

We invite you to visit modernatx.com/careers to learn more about our current opportunities.

Equal Opportunity Statement

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 [e-mail].

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. For assistance completing any forms or otherwise participating in the application process, please call 617-460-9346 or email [e-mail].

Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.