Associate Director – Quality Compliance and Audits
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Job Description
Associate Director managing GMP and GDP audits within Gilead’s quality compliance team. Ensuring regulatory adherence across global manufacturing and supply network with leadership responsibilities.
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, agenda development, audit execution, audit report preparation and issuance
- Develop and execute risk‑based audit strategies and agendas
- Partner cross‑functionally with Gilead stakeholders to obtain relevant background information, risk assessments, and business context in advance of vendor audits
- Identify compliance gaps, quality risks, and systemic issues, and appropriately escalate significant or complex findings to management
Requirements:
- Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience
- 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 across multiple dosage forms and technologies
- Strong working knowledge of risk-based auditing methodologies and the full audit lifecycle
- Excellent written, verbal, and interpersonal communication skills
- Strong organizational, leadership, and time-management skills
Benefits:
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Paid time off
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
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