Senior Director, Global Pharmacovigilance Quality Assurance Lead

Job description

Overview: The Senior Director, Global Pharmacovigilance Quality Assurance Lead provides executive leadership and independent quality oversight of Alnylam’s global pharmacovigilance quality system. Reporting to the Vice President, R&D Quality, the role sets the strategic direction for the GVP QA function and provides independent assurance and escalation regarding the effectiveness of PV procedures, systems, and governance. As Alnylam continues to expand its global portfolio and organizational complexity, the Senior Director will lead the continued evolution of the PV Quality Assurance function, strengthening independent oversight, governance, risk-based assurance, quality-system performance monitoring, and inspection-readiness capabilities to support sustainable growth, operational excellence, and long-term regulatory compliance. This role can be based in Cambridge, MA or Philadelphia, PA in a hybrid work arrangement, or remotely within the United States. Key Responsibilities: Provides strategic leadership for Alnylam’s global Pharmacovigilance (PV) Quality Assurance function, including long-term strategy, operating model, organizational design, talent development, and quality culture grounded in integrity, transparency, and continuous improvement. Leads and evolves the PV QA governance framework, overseeing compliance risk management, quality metrics, trend analysis, management reviews, and escalation of significant quality and regulatory risks. Serves as the independent QA authority for the pharmacovigilance quality system, providing oversight of quality events, CAPAs, compliance assessments, and remediation activities to ensure regulatory compliance and effectiveness. Owns the risk-based GVP audit strategy and PV assurance program. Partners with enterprise audit operations to conduct robust, risk-based audits of internal processes, vendors, and delegated partners while driving continuous improvement and risk mitigation across the PV ecosystem. Provides independent assurance over computerized systems supporting pharmacovigilance, including validation, data integrity, and change control, and oversees GVP QA contributions to the Pharmacovigilance System Master File (PSMF). Leads PV Quality Assurance inspection readiness in partnership with key enterprise stakeholders. Serves as a key representative during global health authority inspections, ensuring effective preparation, response management, and remediation oversight, including independent review of responses and remediation actions. Partners broadly across Safety, Quality, Regulatory, Clinical, Commercial, and enterprise functions to enable compliant execution, strengthen governance, align quality processes, and maintain independent QA decision-making and escalation authority. Qualifications: Bachelor’s degree in a scientific, healthcare, or related discipline; advanced degree such as MSc, PharmD, or PhD preferred. 12-15+ years of experience in pharmacovigilance quality assurance, regulated pharmacovigilance, or a related quality/compliance function, including substantial leadership experience. Thorough knowledge of international GVP regulations and guidance, including FDA requirements, EMA GVP Modules, Health Canada requirements, and applicable ICH guidance; working knowledge of GCP interfaces is expected. Demonstrated success strengthening, scaling, or transforming an independent PV Quality Assurance function, operating model, governance framework, risk-based assurance program, audit strategy, quality metrics, and continuous-improvement capabilities in a matrixed environment. Proven experience with risk-based GVP audits and health-authority inspections, including QPPV and PSMF-related scope. Executive presence and demonstrated ability to align operational, embedded compliance, and independent Quality Assurance stakeholders while preserving clear decision rights and escalation authority. Excellent problem-solving, decision-making, negotiation, communication, and conflict-resolution skills. About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our