About this role

Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners
Manage the end‑to‑end audit lifecycle, including audit planning and scheduling
Develop and execute risk‑based audit strategies and agendas
Partner cross‑functionally with Gilead stakeholders
Contribute to the development, implementation, and continuous improvement of audit procedures
Identify compliance gaps, quality risks, and systemic issues
Ensure consistency, clarity, and quality in audit observation writing
Perform due diligence assessments and supplier qualification activities
Support audit program metrics, continuous improvement initiatives, and established performance goals

Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience
Demonstrated experience in the biotechnology and/or pharmaceutical industry is required
Proven GMP/GDP auditor with experience conducting independent audits
In-depth knowledge of GMP/GDP principles and global regulatory requirements
Comprehensive understanding of manufacturing, testing, and distribution operations
Strong working knowledge of risk-based auditing methodologies
Excellent written, verbal, and interpersonal communication skills
Strong organizational, leadership, and time-management skills

Associate Director – Auditor, Quality Compliance and Audits

Key skills