Director, Global Audit Program
Alnylam PharmaceuticalsWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
The Director, Global Audit Program leads strategy, execution, and oversight of GxP internal and external audit programs, partner audits, hosted audits, self-inspections, and audit-related documentation. This role ensures alignment with regulatory expectations and internal quality objectives, and supports audit preparedness and response efforts. The position reports to the Senior Director, Quality Audits, Inspections & QMS, and collaborates 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 internal audit programs, including supplier/vendor audits, partner-hosted audits, self-inspections, and internal GxP audits.
- Develop, maintain, and execute the annual risk-based audit plan incorporating internal priorities and regulatory trends.
- Maintain awareness of regulatory expectations, industry audit trends, and agency inspection findings to inform audit practices.
- Coordinate with site-based Quality teams to support audit activities, especially hosted audits and inspections.
- Contribute to Quality’s investment planning and budget processes with projections related to audit execution, external resources, travel, training, and system/tool needs.
- Lead or oversee audits across GMP, GDP, GCP, and GLP, including planning, execution, reporting, and CAPA management.
- Collaborate with cross-functional stakeholders to ensure comprehensive audit scope and follow-through.
- Oversee audit-related systems and workflows to ensure documentation is complete and inspection-ready.
- 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 meet quality and compliance expectations.
- Lead audit-related metrics and reporting, including analysis of trends and emerging risks.
- Drive continuous improvement of audit processes, tools, and procedures to increase efficiency and effectiveness.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, or related field is preferred; equivalent relevant industry experience considered.
- Minimum of 10 years in pharmaceutical/biotechnology Quality Assurance with a strong focus on GxP audits and compliance.
- Experience leading comprehensive audit programs and managing internal and external audit plans across diverse GxP areas.
- Strong understanding of global regulatory requirements (FDA, EMA, MHRA, ICH, PIC/S) and their application to audit programs.
- Experience supporting inspections and partner audits, including coordination with site-based teams.
- Excellent communication and collaboration skills; ability to influence cross-functionally.
- Experience with electronic audit systems and quality management tools (e.g., Veeva, AuditUtopia) preferred.
- Ability to travel up to 10–15%, domestic and international travel as needed.