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's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all.

As Senior Manager, Pharmacovigilance Quality Assurance (PVQA), you will report to the Director of PVQA within Research & Development Quality and Compliance (RDQ&C) and be pivotal in building and strengthening Moderna’s PVQA capabilities across EMEA. Acting as a regional quality expert, you will provide strategic oversight across PV quality systems, regulatory compliance, audit strategy, and inspection preparedness—ensuring the safety and compliance of Moderna’s innovative product portfolio.

Your leadership in audits and inspections will have tangible impact, not only ensuring regulatory compliance, but also driving continuous improvement across local and global pharmacovigilance practices. This role demands a confident influencer and strategic thinker with robust GVP auditing experience and a passion for delivering best-in-class quality systems. It also provides a unique opportunity to contribute to cross-functional quality strategy alongside Clinical Safety and Pharmacovigilance (CSPV), Global Medical Affairs (GMA), Global Regulatory Science (GRS), and regional affiliates.

Here’s What You’ll Do:

Your key responsibilities will be:

• Deliver expert PV quality assurance oversight to internal and affiliate stakeholders across the EMEA region.

• Design and lead risk-based pharmacovigilance audits of Moderna affiliates, global PV systems, third-party vendors, and business partners.

• Provide end-to-end GVP inspection readiness support including strategy, coordination, and post-inspection follow-up.

• Drive strategic planning and risk assessment for the global PV audit program, including vendor, system, and affiliate audits.

• Support the development, execution, closure, and escalation of pharmacovigilance-related CAPAs.

Your responsibilities will also include:

• Partner closely with CSPV, GMA, GRS, and affiliates to standardize compliance-related initiatives and implement evolving regulatory requirements.

• Lead early issue detection and contribute to global issue management processes.

• Identify and implement innovative quality and digital enhancements within PVQA, including opportunities to adopt AI tools for audit planning, signal detection, or documentation reviews.

• Stay abreast of evolving PV regulatory guidance and proactively assess implications for audit strategy.

• Actively contribute to the growth of a modern quality culture grounded in accountability, transparency, and digital innovation.

• Participate in cross-functional RDQ&C compliance initiatives.

• Travel up to 30%, with approximately 50% of time dedicated to audits.

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’ll act as the regional pharmacovigilance quality leader, taking full ownership of compliance oversight and risk-based audit execution. Your ability to influence cross-functional stakeholders and proactively steer CAPA strategy reflects our culture of empowered ownership.

• “We digitize everywhere possible using the power of code to maximize our impact on patients.”
  You’ll be encouraged to explore and adopt digital and Generative AI solutions to streamline audit planning, enhance compliance monitoring, and support PV analytics. This mindset will be key to modernizing pharmacovigilance quality systems at Moderna.

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.

• As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

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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