The Role: Reporting to the Director of Pharmacovigilance Quality Assurance (PVQA), Research & Development Quality and Compliance (RDQ&C), the Senior Manager, PVQA, plays a key role in strengthening Moderna’s pharmacovigilance quality function in the region. This position provides strategic oversight of PV quality systems, audits, and inspections while ensuring compliance with global and regional regulatory requirements. The role involves close collaboration with Moderna’s Clinical Safety and Pharmacovigilance (CSPV) organization, Global Regulatory Science (GRS), Global Medical Affairs (GMA), and local affiliates, ensuring consistent implementation of quality standards, regulatory requirements, and compliance-related initiatives. The individual will lead complex pharmacovigilance audits, support regulatory inspections across EMEA, and contribute to CAPA and issue management processes. This position requires an experienced PV quality professional with a strong auditing background, the ability to influence at multiple levels of the organization, and a proactive approach to quality risk management. Here’s What You’ll Do: Provide expert PV quality assurance guidance and support to internal stakeholders, ensuring compliance with global pharmacovigilance regulations and best practices. Plan, conduct, and report on risk-based pharmacovigilance audits of Moderna affiliates, global PV systems, vendors, and business partners. Ensure Moderna affiliates and functions are fully prepared for GVP regulatory inspections, providing strategic support before, during, and after inspections. Ensure end-to-end PV audit activities are timely and compliant. Provide strategic input to the planning and risk-assessment for the global PV audit program (e.g., vendor, system, affiliate, & partner audits). Oversee CAPA development, execution, closure and, as needed, escalation for CAPAs associated or impacting pharmacovigilance. Provide input into the R&D issue management impacting the local and global PV system to ensure early detection of issues, development of corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness. Identify and implement process enhancements to strengthen the PVQA department oversight and ensure regulatory expectations are met. Remain current with industry trends and draft regulations/guidance. Participate in ad-hoc RDQ&C compliance projects and initiatives. Contribute to the continuing development of a quality culture at Moderna. Approximately 50% of time is spent in the audit role. Approximately up to 30% travel required. Here’s What You’ll Bring to the Table: BS/BA (10+ years), MS (8+ years), or Ph D (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 Savingsandinvestments 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 m RNA 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.#LI-DS2-
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