Associate Director, GxP Audits and Inspection Excellence

Alnylam Pharmaceuticals • Cambridge, MA

2d • Hybrid

About The Position

The Associate Director, GxP Audits and Inspection Excellence, serves as the lead for Alnylam’s enterprise audit and inspection program, providing direction, governance, and oversight across all GxP domains. This role is responsible for establishing a unified, risk-based and inspection-ready framework that ensures consistent audit execution, proactive readiness, and transparent Quality oversight aligned with global regulatory expectations.
The Associate Director, reporting to the Head of Audits, Inspection Excellence and QMS (AIQ), leads and directly manages the GxP Audit and Inspection Excellence team. They partner closely with R&D QA, PV QA, Quality Operations, Manufacturing and Technical Operations, Supply Chain, and Quality Technology & Analytics. This role drives standardization, improves inspection transparency, develops advanced audit capabilities, and ensures the organization is prepared for evolving global regulatory scrutiny.

This is a hybrid position and will primarily be located in Cambridge, MA

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; advanced degree preferred.
• 10 years of experience in pharmaceutical/biotechnology Quality Assurance with significant focus on GxP audits, regulatory inspections, and quality systems.
• Demonstrated leadership of enterprise or multi-GxP audit programs, including risk based planning, supplier oversight, and global audit execution.
• Strong understanding of global regulatory frameworks and inspection expectations (e.g., FDA, EMA, MHRA, ICH, PIC/S).
• Proven experience developing and maturing inspection readiness programs and leading cross functional teams through inspections.
• Proficiency with electronic audit and inspection management systems and QMS platforms (e.g., Veeva, ReadyRoom, eQMS).
• Strong communication, facilitation, and stakeholder management skills with the ability to influence without direct authority.
• Demonstrated ability to lead, mentor, and develop team members, promoting high performance and continuous improvement.
• Ability to operate effectively in a dynamic, fast paced, and highly cross functional environment.
• Ability to travel domestically and internationally up to approximately 20%.

Responsibilities

• Serve as the lead for GxP Audits & Inspection Excellence, providing strategic direction, governance, and oversight across all audit and inspection activities.
• Lead development and execution of the enterprise risk-based audit strategy, consolidating the GxP audit universe and ensuring consistency across internal and external audits.
• Oversee global inspection readiness programs, including readiness strategies, cross-functional preparation, and standardized inspection management processes.
• Ensure consistent global management of regulatory inspections, including documentation readiness, backroom operations, evidence management, and communication pathways.
• Govern post inspection activities, including response quality, commitment tracking, timeliness, and systemic issue identification.
• Provide leadership and oversight of audit and inspection tools, systems, and dashboards, ensuring data integrity, transparency, and strategic insight.
• Partner cross functionally to integrate audit and inspection findings into QMS processes, Quality Risk Management, and enterprise reporting.
• Champion continuous improvement of audit and inspection procedures, templates, guidance, and training materials.
• Oversee operational delivery of audits and inspections through management of the GxP Inspection Oversight & Audit Management team.
• Ensure robust CAPA tracking and effectiveness evaluation following audits and inspections.
• Provide senior level reporting, insights, and trend analysis to Quality leadership and governance forums.
• Drive organizational alignment, competency development, and a culture of proactive inspection readiness across all GxP areas.

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees