Associate Director – Auditor, Quality Compliance and Audits
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Job Description
Associate Director / Auditor responsible for global GMP and GDP audits in biopharmaceuticals. Ensuring compliance and continuous improvement in Gilead's manufacturing and supply network.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance plans
- Paid time off
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
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