Senior Manager, Global Pharmacovigilance; PV) Quality Assurance

Why is this role open? Team structure/coverage needs;

New manager recently took over the function. Day-to-day work:
Global PV Quality Assurance with a strong focus on auditing and QA operations. Support GVP audits, quality events, CAPAs, deviations, change controls, and quality management system activities. Support PV system oversight, inspection readiness, vendor oversight, and PSMF activities. Partner cross-functionally with PV and other GxP teams.

Work hours:

40 hours/week Monday Friday, standard business hours. No weekend work.

Location:

Cambridge or Philadelphia preferred. Open to candidates in different time zones but prefer EST/CST;not PST. Some travel will be required for audits. Target start date: ASAP Contract end date: 12/31/2027 Bill Rate: $150/hour

• Primary focus:
  Specifically looking for a quality-focused PV professional with strong auditing and QA operations experience, rather than someone whose background is primarily compliance.
• Must-have experience: 10+ years of experience;very seasoned candidate who can hit the ground running.
• Strong GVP auditing and QA experience.
• Experience with QA operations.
• Experience with deviation management/review, CAPAs, and quality events.
• Experience with change controls and Quality Management System (QMS) lifecycle.
• Strong understanding of PV regulations/GVP requirements.
• Experience with or strong familiarity with the Pharmacovigilance System Master File (PSMF).
• Pharmaceutical industry experience in a quality/QA function.
• Experience supporting audits and/or inspection readiness.
• Minimum Bachelor s degree, preferably in life sciences.

• Master s or PhD, particularly a PharmD/PhD in Pharmacy.
• Experience with Digital QMS, Veeva, Quality Vault, and related quality systems.
• Experience with PV/PMS vendors and licensing partners.
• Experience with global GVP regulations, FDA PV requirements, Health Authority guidance, and ICH.
• Experience supporting Health Authority inspections.

• Provide Quality oversight of Alnylam s global postmarketing PV system.
• Support development and execution of the global GVP audit program.
• Conduct/execute audits of licensing partners, vendors, affiliates, internal teams, and service providers.
• Evaluate Quality Events, deviations, root cause analyses, and CAPAs.
• Support risk-based audit strategy and maintain the PV audit universe and audit schedule.
• Provide audit, CAPA, and supplier data for the PSMF.
• Develop and maintain audit processes, tools, and quality metrics.
• Support PV/PMS inspection readiness and inspection management.
• Provide Quality oversight of PV/PMS vendors.
• Support Quality Agreements, KQIs, vendor qualification, and audits.
• Support GVP QA training and process improvement initiatives.

• Self-motivated and able to work independently. Does not wait for direction;takes initiative and drives work forward.
• Strong analytical and problem-solving skills.
• Comfortable handling complex and sensitive quality issues.
• Strong communication and cross-functional collaboration skills.
• Diplomatic and professional when addressing sensitive issues.
• Strategic thinker with a continuous-improvement mindset.