Global PV QA Executive Leader - Remote/Hybrid

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 228,000 - 308,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Senior Director, Global Pharmacovigilance Quality Assurance Lead to provide executive leadership and independent oversight of the PV quality system. The role sets strategy for PV QA, drives governance, and ensures regulatory compliance across the global PV ecosystem.

Based in Cambridge, MA or Philadelphia, PA in a hybrid setup, or remote within the United States, the role partners with Safety, Regulatory, and Enterprise functions to maintain QA decision rights and

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline.
• Advanced degree such as MSc, PharmD, or PhD preferred.

Responsibilities

• Lead and evolve the PV QA governance framework and risk-based assurance program.
• Oversee quality events, CAPAs, and remediation activities for regulatory compliance.

Skills

Leadership

PV QA

Governance

Risk-based QA

Audits

Inspection Readiness

Data Integrity

Validation

Change Control

GVP Knowledge

Collaboration

Executive Presence

Communication

Negotiation

Conflict Resolution

Education

Bachelor's degree

Advanced degree preferred

Job description

Alnylam Pharmaceuticals seeks a Senior Director, Global Pharmacovigilance Quality Assurance Lead to provide executive leadership and independent oversight of the PV quality system. The role sets strategy for PV QA, drives governance, and ensures regulatory compliance across the global PV ecosystem.

Based in Cambridge, MA or Philadelphia, PA in a hybrid setup, or remote within the United States, the role partners with Safety, Regulatory, and Enterprise functions to maintain QA decision rights and