Global PV Quality Assurance Executive Leader

Alnylam Pharmaceuticals; United States; Hybrid; USD 228,000 - 308,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Senior Director, Global Pharmacovigilance Quality Assurance to provide strategic leadership for the global PV quality system and independent assurance of PV procedures, systems, and governance. This role may be based in Cambridge, MA or Philadelphia, PA in a hybrid setup, or remotely within the United States.

The position leads the PV QA governance framework, risk-based audit strategy, and inspection readiness, partnering with Safety, Quality, Regulatory,

Qualifications

• 12–15+ years in PV quality assurance or related function.
• Thorough knowledge of international GVP regulations and guidance; FDA/EMA/I CH.
• Experience building/scaling an independent PV QA function in a matrix environment.
• Executive presence; ability to align stakeholders and maintain escalation rights.
• Experience with health-authority inspections and QPPV/PSMF scope.

Responsibilities

• Provide strategic leadership for PV QA function, governance framework, and risk-based assurance.
• Oversee quality events, CAPAs, regulatory risk management, and remediation activities.
• Lead PV QA audit strategy and collaborate with enterprise audit operations.
• Assure computerized PV systems, data integrity, validation, and change control.
• Lead PV QA inspection readiness and manage responses during inspections.
• Collaborate across Safety, Quality, Regulatory, Clinical, and enterprise functions.

Skills

Executive leadership

PV Quality Assurance

Risk-based assurance

GVP audits

Regulatory compliance

Cross-functional collaboration

Communication

Education

Bachelor's degree; MSc/PhD preferred

Job description

Alnylam Pharmaceuticals seeks a Senior Director, Global Pharmacovigilance Quality Assurance to provide strategic leadership for the global PV quality system and independent assurance of PV procedures, systems, and governance. This role may be based in Cambridge, MA or Philadelphia, PA in a hybrid setup, or remotely within the United States.

The position leads the PV QA governance framework, risk-based audit strategy, and inspection readiness, partnering with Safety, Quality, Regulatory,