Director, Quality Compliance and Audits
Gilead Sciences
6 hours ago
Remote friendly (Washington, DC)
United States
Operations
Director, Quality Compliance and Audits (QCA)
Responsibilities
- Provide strategic leadership and governance for the global GMP and GDP audit program.
- Lead and develop a team of auditors; ensure consistent, high-quality audit execution across internal and external manufacturing/supply partners.
- Oversee the end-to-end audit lifecycle, including development and execution of the annual risk-based audit plan.
- Ensure audits are systematic, independent, and objective assessments of compliance with global regulatory requirements, internal quality policies, and industry standards.
- Partner with cross-functional stakeholders to document, escalate, trend, and resolve compliance risks and systemic issues.
- Monitor regulatory requirements, enforcement trends, and inspection intelligence; incorporate insights into audit planning and coverage.
- Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms; incorporate trends into audit strategy.
- Conduct/support global GMP and GDP audits of internal sites and external partners (contract manufacturers, labs, suppliers, distributors, and other third parties) across modalities (small molecules, biologics, medical devices/combination products).
- Drive consistency and quality in observation writing, finding classification, risk assessment, and documentation.
- Identify, assess, and appropriately escalate compliance risks and systemic issues.
- Evaluate and govern use of AI-enabled tools and digital solutions to improve audit effectiveness, consistency, and efficiency.
- Collaborate to identify compliance gaps, emerging risks, and opportunities for proactive compliance/continuous improvement.
- Provide expert guidance on interpretation and application of GMP/GDP and regulatory requirements.
- Develop and implement processes, procedures, tools, templates, and systems to maintain a robust global audit program.
- Oversee systems and data used to manage the audit program, ensuring accuracy and integrity.
Supervisory Responsibilities
- Supervise direct reports; supervise contingent workforce and consultants.
- Develop talent (mentoring and development planning) for direct and indirect reports.
Qualifications / Required & Preferred Skills
- Demonstrated experience in biotechnology or pharmaceutical industry (required).
- Proven GMP/GDP auditor with experience conducting audits and leading/managing/developing an auditing team (required).
- Expert knowledge of GMP and GDP regulations, global regulatory expectations, and inspection practices (required).
- Excellent verbal, written, and interpersonal communication skills across technical, operational, and executive audiences.
- Ability to listen to and integrate diverse perspectives; advocate for well-reasoned solutions.
- Demonstrated accountability, results orientation, and ability to learn from experience and feedback.
- Sound judgment and analytical thinking to collect, evaluate, and synthesize information for independent decisions.
- Ability to communicate, influence, and escalate issues and decisions for risk-based, timely resolution.
- Experience engaging with Health Authorities during regulatory inspections (desirable).
- Prior experience within a regulatory authority (desirable).
Education/Experience
- BS/BA in Biology/Sciences (or related) + minimum 12 years related experience; or
- MS/MA in Biology/Sciences (or related) + minimum 10 years related experience; or
- Equivalent combination of education and experience.
Travel
- 30% travel required.
Benefits (as stated)
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- For current Gilead employees and contractors: Apply via the Internal Career Opportunities portal in Workday.
Responsibilities
- Provide strategic leadership and governance for the global GMP and GDP audit program.
- Lead and develop a team of auditors; ensure consistent, high-quality audit execution across internal and external manufacturing/supply partners.
- Oversee the end-to-end audit lifecycle, including development and execution of the annual risk-based audit plan.
- Ensure audits are systematic, independent, and objective assessments of compliance with global regulatory requirements, internal quality policies, and industry standards.
- Partner with cross-functional stakeholders to document, escalate, trend, and resolve compliance risks and systemic issues.
- Monitor regulatory requirements, enforcement trends, and inspection intelligence; incorporate insights into audit planning and coverage.
- Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms; incorporate trends into audit strategy.
- Conduct/support global GMP and GDP audits of internal sites and external partners (contract manufacturers, labs, suppliers, distributors, and other third parties) across modalities (small molecules, biologics, medical devices/combination products).
- Drive consistency and quality in observation writing, finding classification, risk assessment, and documentation.
- Identify, assess, and appropriately escalate compliance risks and systemic issues.
- Evaluate and govern use of AI-enabled tools and digital solutions to improve audit effectiveness, consistency, and efficiency.
- Collaborate to identify compliance gaps, emerging risks, and opportunities for proactive compliance/continuous improvement.
- Provide expert guidance on interpretation and application of GMP/GDP and regulatory requirements.
- Develop and implement processes, procedures, tools, templates, and systems to maintain a robust global audit program.
- Oversee systems and data used to manage the audit program, ensuring accuracy and integrity.
Supervisory Responsibilities
- Supervise direct reports; supervise contingent workforce and consultants.
- Develop talent (mentoring and development planning) for direct and indirect reports.
Qualifications / Required & Preferred Skills
- Demonstrated experience in biotechnology or pharmaceutical industry (required).
- Proven GMP/GDP auditor with experience conducting audits and leading/managing/developing an auditing team (required).
- Expert knowledge of GMP and GDP regulations, global regulatory expectations, and inspection practices (required).
- Excellent verbal, written, and interpersonal communication skills across technical, operational, and executive audiences.
- Ability to listen to and integrate diverse perspectives; advocate for well-reasoned solutions.
- Demonstrated accountability, results orientation, and ability to learn from experience and feedback.
- Sound judgment and analytical thinking to collect, evaluate, and synthesize information for independent decisions.
- Ability to communicate, influence, and escalate issues and decisions for risk-based, timely resolution.
- Experience engaging with Health Authorities during regulatory inspections (desirable).
- Prior experience within a regulatory authority (desirable).
Education/Experience
- BS/BA in Biology/Sciences (or related) + minimum 12 years related experience; or
- MS/MA in Biology/Sciences (or related) + minimum 10 years related experience; or
- Equivalent combination of education and experience.
Travel
- 30% travel required.
Benefits (as stated)
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- For current Gilead employees and contractors: Apply via the Internal Career Opportunities portal in Workday.