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 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.

Modernas mission is to establish a leadingedge research development and manufacturing facility at Harwell as part of a longterm 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. Were looking for global experts eager to join us in this endeavour contributing to a future where access to lifesaving 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 Modernas 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 preparednessensuring the safety and compliance of Modernas 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 bestinclass quality systems. It also provides a unique opportunity to contribute to crossfunctional quality strategy alongside Clinical Safety and Pharmacovigilance (CSPV) Global Medical Affairs (GMA) Global Regulatory Science (GRS) and regional affiliates.

Heres What Youll Do:

Your key responsibilities will be:

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

• Design and lead riskbased pharmacovigilance audits of Moderna affiliates global PV systems thirdparty vendors and business partners.

• Provide endtoend GVP inspection readiness support including strategy coordination and postinspection followup.

• 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 pharmacovigilancerelated CAPAs.

Your responsibilities will also include:

• Partner closely with CSPV GMA GRS and affiliates to standardize compliancerelated 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 crossfunctional RDQ&C compliance initiatives.

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

The key Moderna Mindsets youll need to succeed in the role:

• We behave like owners. The solutions were building go beyond any job description.
  Youll act as the regional pharmacovigilance quality leader taking full ownership of compliance oversight and riskbased audit execution. Your ability to influence crossfunctional 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.
  Youll 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.

Heres What Youll 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.

• Indepth knowledge of relevant FDA EMA pharmacovigilance guidelines and local/regional GVP regulations.

• Handson 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 fastpaced environment.

• Ability to collaborate effectively in a dynamic crossfunctional matrix environment.

• As part of Modernas commitment to workplace safety this role may require an enhanced preemployment check.

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 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 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 .