Director, Global Audit Program

Role Summary

The Director, Global Audit Program leads strategy, execution, and oversight of Alnylam’s GxP internal and external audits, including supplier/vendor audits, hosted audits, self-inspections, and related documentation. They ensure alignment with regulatory expectations, industry best practices, and internal quality objectives, and support audit preparedness and response. Reporting to the Senior Director, Quality Audits, Inspections & QMS, they drive enterprise-wide audit planning, governance, and follow-up across audits performed or hosted by Alnylam Quality, collaborating with 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.

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 Management) 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

• 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-functional and influence without direct authority.
• Experience with electronic audit systems and quality management tools (e.g., Veeva, AuditUtopia) preferred.

Education

• Bachelor’s degree in life sciences, pharmacy, or a related field is preferred; equivalent relevant industry experience will also be considered.

Skills

• Strong communication and cross-functional collaboration.
• Strategic leadership and program management for audit initiatives.
• Regulatory knowledge of global requirements (FDA, EMA, MHRA, ICH, PIC/S).
• Experience with electronic audit systems and quality management tools (e.g., Veeva, AuditUtopia).

Additional Requirements

• Travel up to 10–15%, including international travel as needed.