Director, Quality Compliance and Audits
Gilead Sciences
August 14, 2026
Remote friendly (Washington, DC)
United States
Operations
Director, Quality Compliance and Audits (QCA)
Essential Duties and Responsibilities:
- Lead and develop a global GMP/GDP audit program; manage and develop an auditing team (work planning, prioritization, performance monitoring, coaching, feedback, performance reviews).
- Foster a culture of quality, accountability, and continuous improvement.
- Serve on the Quality Compliance & Audits Leadership Team to define strategy and collaborate cross-functionally.
- Establish and execute a risk-based annual audit plan.
- Monitor regulatory requirements, enforcement trends, and inspection intelligence; incorporate insights into audit planning.
- Promote awareness of regulatory expectations across clinical and commercial manufacturing; incorporate trends into audit strategy.
- Conduct/support global GMP and GDP audits of internal sites and external partners (contract manufacturers, laboratories, suppliers, distributors, and other third parties) across small molecules, biologics, and medical devices/combination products.
- Ensure consistency in audit observation writing, finding classification, risk assessment, and documentation.
- Identify, assess, and escalate compliance risks/systemic issues for timely evaluation and resolution.
- Evaluate and implement AI-enabled tools and digital solutions to improve audit effectiveness, consistency, and efficiency.
- Provide expert guidance on interpretation and application of GMP/GDP and related regulatory requirements.
- Support development/implementation of processes, procedures, tools, templates, and systems for the audit program.
- Oversee audit program systems/data to ensure accuracy and integrity.
Supervisory Responsibilities:
- Supervise direct reports; contingent workforce/consultants.
- Develop talent for direct and indirect reports through mentoring.
Experience/Knowledge/Skills:
- Biotechnology/pharmaceutical industry experience (required).
- Proven GMP/GDP auditor; experience conducting audits and leading/managing/developing auditors (required).
- Health Authority inspection engagement experience (desirable).
- Regulatory authority experience (desirable).
- Expert knowledge of GMP/GDP regulations, global expectations, and inspection practices.
- Strong verbal/written/interpersonal communication across technical/operational/executive audiences.
- Ability to integrate diverse perspectives; accountability and results orientation.
- Sound analytical judgment; effective escalation and communication.
Education/Experience:
- BS/BA in Biology/Sciences (or related) + 12+ years related experience; or MS/MA + 10+ years; or equivalent education/experience.
Travel:
- 30% travel required.
Essential Duties and Responsibilities:
- Lead and develop a global GMP/GDP audit program; manage and develop an auditing team (work planning, prioritization, performance monitoring, coaching, feedback, performance reviews).
- Foster a culture of quality, accountability, and continuous improvement.
- Serve on the Quality Compliance & Audits Leadership Team to define strategy and collaborate cross-functionally.
- Establish and execute a risk-based annual audit plan.
- Monitor regulatory requirements, enforcement trends, and inspection intelligence; incorporate insights into audit planning.
- Promote awareness of regulatory expectations across clinical and commercial manufacturing; incorporate trends into audit strategy.
- Conduct/support global GMP and GDP audits of internal sites and external partners (contract manufacturers, laboratories, suppliers, distributors, and other third parties) across small molecules, biologics, and medical devices/combination products.
- Ensure consistency in audit observation writing, finding classification, risk assessment, and documentation.
- Identify, assess, and escalate compliance risks/systemic issues for timely evaluation and resolution.
- Evaluate and implement AI-enabled tools and digital solutions to improve audit effectiveness, consistency, and efficiency.
- Provide expert guidance on interpretation and application of GMP/GDP and related regulatory requirements.
- Support development/implementation of processes, procedures, tools, templates, and systems for the audit program.
- Oversee audit program systems/data to ensure accuracy and integrity.
Supervisory Responsibilities:
- Supervise direct reports; contingent workforce/consultants.
- Develop talent for direct and indirect reports through mentoring.
Experience/Knowledge/Skills:
- Biotechnology/pharmaceutical industry experience (required).
- Proven GMP/GDP auditor; experience conducting audits and leading/managing/developing auditors (required).
- Health Authority inspection engagement experience (desirable).
- Regulatory authority experience (desirable).
- Expert knowledge of GMP/GDP regulations, global expectations, and inspection practices.
- Strong verbal/written/interpersonal communication across technical/operational/executive audiences.
- Ability to integrate diverse perspectives; accountability and results orientation.
- Sound analytical judgment; effective escalation and communication.
Education/Experience:
- BS/BA in Biology/Sciences (or related) + 12+ years related experience; or MS/MA + 10+ years; or equivalent education/experience.
Travel:
- 30% travel required.