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

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionising medicine through mRNA technology, with a diverse pipeline of development programmes across various diseases. As an employee, you will be part of a continually growing organisation, 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 are 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.

This role will be instrumental in strengthening Moderna’s pharmacovigilance quality assurance activities in the EMEA region. As a strategic quality leader, you will collaborate closely with Clinical Safety and Pharmacovigilance, Global Regulatory Science, and Global Medical Affairs teams—alongside local affiliates—to ensure compliance with evolving regulatory standards. Your expertise in audits and inspections will be critical to upholding Moderna’s commitment to patient safety and operational excellence.

Here’s What You’ll Do

• Provide expert PVQA guidance to internal teams, ensuring alignment with global and regional regulatory frameworks.
• Lead risk-based pharmacovigilance audits across affiliates, global systems, vendors, and partners.
• Support strategic planning and execution of the global PV audit program.
• Ensure robust inspection readiness for Moderna’s global pharmacovigilance operations.
• Oversee full CAPA lifecycle management for findings impacting PV systems and operations.

Your Responsibilities Will Also Include

• Support issue detection, CAPA development, and effectiveness assessments within R&D quality systems.
• Continuously improve PVQA oversight processes and elevate internal quality culture.
• Track and respond to evolving regulatory expectations and global trends in pharmacovigilance.
• Mentor junior auditors and contribute to training initiatives.
• Collaborate cross-functionally with CSPV, GMA, and GRS to drive compliance excellence.

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.” In this strategic and independent position, your ownership of complex audits, CAPA implementation, and compliance initiatives will be vital to Moderna’s patient-first mission. You’ll lead with accountability and influence across a highly matrixed organisation.
• “We digitise everywhere possible using the power of code to maximise our impact on patients.” You will be working within a quality culture that embraces digital transformation, opening opportunities to integrate advanced analytics, audit tools, and emerging technologies—including generative AI—into PVQA oversight, amplifying speed, accuracy, and impact.

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 organise 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 organisation that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognised as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

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, colour, 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.