Senior Manager, Quality Assurance (PVQA)

Overview This role is a member of the GVP QA team providing global PV Quality Assurance oversight of Alnylam’s post‑marketing pharmacovigilance system, with a focus on PV audit execution, vendor quality oversight, CAPA management, and PSMF support. This role leads and executes the global PV audit program and partners cross‑functionally to strengthen PV quality processes. This position reports to the Associate Director, Global PV Quality Assurance and frequently interacts with cross-functional teams. This role is hybrid 2 days/week based in our Maidenhead, UK or Amsterdam, The Netherlands office. Key Responsibilities * Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system through PV quality audits, risk‑based quality oversight, and continuous improvement of PV processes. * Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP) * Support cross GxP QA activities requiring PV and PMS expertise. * Lead and execute global PV quality audits for licensing partners, external PV vendors, internal functions, affiliates, and other applicable service providers in a post‑marketing environment. * Determine, evaluate and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions. * Effectively communicate and escalate critical matters to management. * Own and drive the Global PV Strategic Audit Program, including development of risk‑based PV audit strategy, maintenance of the PV audit universe and risk tools, and creation of global PV audit plans and schedules. * Determine, evaluate and investigate PV Quality Events. Own and drive root cause analysis, CAPA development, implementation, and effectiveness checks for PV audits and vendor oversight activities. * Effectively communicate and escalate critical matters to management. * Support the Global Strategic Audit Program - contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule. * Own and execute PVQA contributions to the PV System Master File (PSMF), including compiling, maintaining, and providing audit, CAPA, and supplier quality information to ensure comprehensive and accurate PSMF content * Develop and maintain processes and tools to support quality audit execution and outcomes. * Act as the primary operational PVQA owner and QA contact for global PV, PMS, and PV‑related vendors, including audit planning and execution, CAPA management, and ongoing vendor quality oversight. * Develop and report GVP QA metrics and dashboards to support quality oversight. * Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs. * Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions. * Other assignments as directed. Qualifications * Educated to university degree (preferably life sciences) or equivalent qualification or experience * Extensive experience in the pharmaceutical industry within global Pharmacovigilance Quality Assurance (PVQA), including PV audit execution and vendor quality oversight. * Audit skills and experience of conducting GVP audits is preferred. * Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidance and ICH. * Experience supporting Health Agency inspections. * Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement. * Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships. * Diplomatic in addressing sensitive issues confidentially and professionally. Works professionally with confidential information. * Ability to analyse complex situations / issues. Demonstrates strategic thinking About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.