alnylampharmaceuticals · Cambridge, MA; Philadelphia, PA; Virtual
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…
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