Director, Global Audit Program

Overview

The Director, Global Audit Program is responsible for leading the strategy, execution, and oversight of Alnylam’s GxP internal and external audit programs; as well as partner audit programs, including supplier/vendor audits, hosted audits, self-inspections, and audit-related documentation. This role ensures alignment with evolving regulatory expectations, best practices, and internal quality objectives, and plays an active role in supporting audit preparedness and response efforts.

Reporting to the Senior Director, Quality Audits, Inspections & QMS (QAI-QMS), the Director leads enterprise-wide audit planning and ensures appropriate documentation, governance, and follow-up across all audits performed or hosted by Alnylam Quality. This role collaborates closely with functions across Quality, Technical Operations, Regulatory, and site-based Quality teams to ensure alignment, visibility, and readiness.

This position can be hybrid, onsite, or remote, with a preference for the US.  

Key Responsibilities

• Provide strategic leadership for Alnylam’s internal audit programs, encompassing supplier/vendor audits, partner-hosted audits, self-inspections, and internal GxP audits across development and commercial operations.
• Develop, maintain, and execute the annual risk-based audit plan, incorporating internal priorities, partner expectations, and regulatory trends.
• Maintain active awareness of regulatory expectations, industry audit trends, and agency inspection findings to inform and evolve audit practices.
• Partner with site-based Quality teams to support coordination, logistics, and continuous improvement of audit-related activities, particularly for hosted audits and inspections.
• Contribute to Quality’s investment planning (IP) and budget processes by providing projections related to audit execution, external resources, travel, training, and system/tool needs.
• Lead or oversee audits across multiple GxP domains (GMP, GDP, GCP, GLP), including planning, execution, reporting, and CAPA management.
• Collaborate with cross-functional stakeholders (e.g., Procurement, Quality Operations, Clinical Quality, Manufacturing, Alliance Managemenr) to ensure comprehensive audit scope and consistent follow-through.
• Oversee audit-related systems and workflows, ensuring that documentation is complete, inspection-ready, and meets regulatory and internal requirements.
• Support regulatory inspections and partner audits hosted by Alnylam by participating in planning, preparation, execution, and documentation.
• Contribute to auditor training and qualification processes; ensure practices are consistent and meet Alnylam’s expectations for quality and compliance.
• Lead audit-related metrics and reporting activities, including analysis of trends, themes, and emerging risks.
• Drive continuous improvement of audit processes, tools, and procedures to increase efficiency, consistency, and effectiveness across the program

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field is preferred; equivalent relevant industry experience will also be considered.
• Minimum of 10 years of experience in pharmaceutical or biotechnology Quality Assurance, with a strong focus on GxP audits and compliance.
• Demonstrated experience leading comprehensive audit programs and managing internal and external audit plans across diverse GxP areas.
• Strong understanding of global regulatory requirements and standards (e.g., FDA, EMA, MHRA, ICH, PIC/S) and their application to audit programs.
• Experience supporting inspections and partner audits, including coordination with site-based teams and backroom planning.
• Excellent communication and collaboration skills with the ability to work cross-functionally and influence without direct authority.
• Experience with electronic audit systems and quality management tools (e.g., Veeva, AuditUtopia) preferred.
• Ability to travel up to 10–15%, between domestic sites and including international travel as needed.

U.S. Pay Range

$187,000.00 - $253,000.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer 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. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.