Manager GxP Systems

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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 Modernas global business operations. Were 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 computerbased 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 Youll 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 recordkeeping 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 .

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

The key Moderna Mindsets youll 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 auditready 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 Youll Need (Basic Qualifications):

• Bachelors 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 problemsolving skills.

• Ability to manage multiple projects and tasks in a fastpaced 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.

• Detailoriented with a commitment to accuracy and quality.

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to wellbeing
• 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 yearend shutdown
• Savingsandinvestments
• Locationspecific 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 theinfrastructure to reimagine how medicines are created and delivered and a worldclass 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 peopleare 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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.

Were 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 .