Global PV QA Exec Director — Hybrid/Remote, Inspection-Ready

Alnylam Pharmaceuticals; Philadelphia (Philadelphia County); Hybrid; USD 228,000 - 308,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Senior Director, Global Pharmacovigilance Quality Assurance Lead to provide executive leadership and independent oversight of the global PV quality system. This role guides strategy, governance, and risk-based assurance to support compliance and growth.

Hybrid work options include Cambridge, MA or Philadelphia, PA or remote within the United States. The role partners with Safety, Quality, Regulatory, and Clinical teams to enable compliant execution and

Qualifications

• Broad knowledge of international GVP regulations and guidance; FDA/EMA/Health Canada familiarity.
• Proven ability to design and scale an independent PV QA function in a matrix environment.
• Experience with risk-based audits and health-authority inspections, including QPPV/PSMF context.
• Executive presence enabling alignment of stakeholders while preserving decision rights.

Responsibilities

• Provide strategic leadership for global PV QA function and governance.
• Oversee quality events, CAPAs, and remediation to ensure regulatory compliance.
• Own risk-based PV audit strategy and partner with enterprise audit operations.
• Lead inspection readiness and represent PV QA during global health authority inspections.
• Ensure validation, data integrity, and change control for PV computerized systems.

Skills

PV QA leadership

Regulatory compliance

GVP audits

Executive communication

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Alnylam Pharmaceuticals is seeking a Senior Director, Global Pharmacovigilance Quality Assurance Lead to provide executive leadership and independent oversight of the global PV quality system. This role guides strategy, governance, and risk-based assurance to support compliance and growth.

Hybrid work options include Cambridge, MA or Philadelphia, PA or remote within the United States. The role partners with Safety, Quality, Regulatory, and Clinical teams to enable compliant execution and