Senior Manager, Pharmacovigilance Quality Assurance, R&D Quality and Compliance

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 a key individual contributor reporting to the Director of Pharmacovigilance Quality Assurance (PVQA) within the Research & Development Quality and Compliance (RDQ&C) organization, the Senior Manager, PVQA will play a central role in strengthening Moderna’s pharmacovigilance quality oversight across the EMEA region. This strategic position is responsible for managing pharmacovigilance audits, supporting regulatory inspections, and driving global compliance with GVP and regulatory standards.

With approximately 50% of your time dedicated to leading complex audits and up to 30% travel, you will collaborate closely with Clinical Safety and Pharmacovigilance (CSPV), Global Regulatory Science (GRS), Global Medical Affairs (GMA), and Moderna’s regional affiliates. The ideal candidate is a seasoned PVQA expert with deep auditing experience and a proactive, influential approach to quality risk management.

Here’s What You’ll Do:

Your key responsibilities will be:

• Provide expert PV quality assurance guidance to cross-functional stakeholders, ensuring alignment with international pharmacovigilance regulations and best practices.

• Lead risk-based pharmacovigilance audits for Moderna’s affiliates, vendors, global PV systems, and business partners.

• Ensure comprehensive GVP inspection readiness across the EMEA region and lead strategic support throughout inspection cycles.

• Oversee and ensure timely execution and compliance of end-to-end audit activities.

• Deliver strategic input into risk-based global PV audit program planning.

Your responsibilities will also include:

• Oversee CAPA (Corrective and Preventive Action) processes — development, execution, escalation, and closure — particularly for PV-related quality issues.

• Actively participate in R&D issue management to ensure early detection, tracking, resolution, and effectiveness assessment of PV quality issues.

• Identify and implement process improvements to enhance PVQA oversight and align with evolving regulatory expectations.

• Stay current with evolving industry trends, draft regulations, and best practices.

• Engage in broader RDQ&C compliance initiatives and champion Moderna’s quality culture globally.

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

• “We behave like owners. The solutions we’re building go beyond any job description.”
  You will be empowered to proactively identify gaps and solutions across global PV systems, taking full ownership of audit and inspection processes while driving excellence independently across regional and global stakeholders.

• “We digitize everywhere possible using the power of code to maximize our impact on patients.”
  Your role offers opportunities to work at the intersection of quality and technology, enabling enhanced audit practices and potential engagement with Generative AI tools for risk analysis and CAPA optimization.

Here’s What You’ll Bring to the Table:

• BS/BA (10+ years), MS (8+ years), or PhD (7+ years) in Life Sciences, Pharmacy, or a related field.

• Extensive experience in pharmacovigilance operations and/or GVP Quality Assurance within a global biotech, pharmaceutical, or CRO environment.

• In-depth knowledge of relevant FDA, EMA, pharmacovigilance guidelines, and local/regional GVP regulations.

• Hands-on experience of planning, leading, and reporting on global pharmacovigilance audits

• Experienced in CAPA management and issue resolution

• Working knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations preferred.

• Experience working with CROs, vendors, and relationship management preferred.

• Excellent auditing skills and ability to communicate significant observations to internal and external stakeholders in a sound and factual manner. 

• Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.

• Strong leadership skills with ability to effectively organize and execute tasks.

• Ability to work both independently and in a team environment.

• Excellent communication and presentation skills, both verbal and written.

• Ability to influence and negotiate effective solutions, excellent interpersonal skills.

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

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

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 leavesandaccommodations@modernatx.com. 

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