Director, Quality Compliance and Audits
Gilead Sciences
5 hours ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Responsibilities:
- Provide strategic leadership and governance for Gilead’s global GMP and GDP audit program.
- Lead and develop a team of auditors; ensure consistent, high-quality audit execution across internal facilities, contract manufacturers, laboratories, suppliers, distributors, and other third parties.
- 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; drive consistency, continuous improvement, and sustained quality oversight.
- 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 and incorporate trends into audit strategy.
- Conduct/support global GMP and GDP audits across modalities (small molecules, biologics, medical devices/combination products).
- Drive consistency and quality in audit observation writing, finding classification, risk assessment, and documentation.
- Evaluate, govern, and implement appropriate AI-enabled tools and digital solutions to enhance audit effectiveness, consistency, and efficiency.
- Provide expert guidance on interpretation/application of regulatory requirements for complex compliance matters.
- Support development and implementation of processes, procedures, tools, templates, and systems for the 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.
- Mentor and develop talent for direct and indirect reports.
Qualifications / Required skills:
- Demonstrated experience in biotechnology or pharmaceutical industry.
- Proven GMP/GDP auditor with experience conducting audits and leading/managing/developing an auditing team.
- Expert knowledge of GMP and GDP regulations, global regulatory expectations, and inspection practices.
- Excellent verbal, written, and interpersonal communication across technical, operational, and executive audiences.
- Accountability, results orientation, and ability to learn from feedback.
- Sound judgment and analytical thinking to support independent, timely decision-making.
- Ability to communicate, influence, and escalate issues/decisions to support risk-based resolution.
Preferred skills:
- Experience engaging with Health Authorities during regulatory inspections.
- Prior experience within a regulatory authority.
Education / Experience:
- BS/BA in Biology/Sciences or related discipline plus 12+ years related experience; or
- MS/MA in Biology/Sciences or related discipline plus 10+ years related experience; or
- Equivalent combination of education and experience.
Travel:
- 30% travel required.
Benefits:
- Company-sponsored medical, dental, vision, and life insurance plans (plus potential discretionary annual bonus, stock-based long-term incentives, and paid time off).
Application instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
- Provide strategic leadership and governance for Gilead’s global GMP and GDP audit program.
- Lead and develop a team of auditors; ensure consistent, high-quality audit execution across internal facilities, contract manufacturers, laboratories, suppliers, distributors, and other third parties.
- 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; drive consistency, continuous improvement, and sustained quality oversight.
- 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 and incorporate trends into audit strategy.
- Conduct/support global GMP and GDP audits across modalities (small molecules, biologics, medical devices/combination products).
- Drive consistency and quality in audit observation writing, finding classification, risk assessment, and documentation.
- Evaluate, govern, and implement appropriate AI-enabled tools and digital solutions to enhance audit effectiveness, consistency, and efficiency.
- Provide expert guidance on interpretation/application of regulatory requirements for complex compliance matters.
- Support development and implementation of processes, procedures, tools, templates, and systems for the 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.
- Mentor and develop talent for direct and indirect reports.
Qualifications / Required skills:
- Demonstrated experience in biotechnology or pharmaceutical industry.
- Proven GMP/GDP auditor with experience conducting audits and leading/managing/developing an auditing team.
- Expert knowledge of GMP and GDP regulations, global regulatory expectations, and inspection practices.
- Excellent verbal, written, and interpersonal communication across technical, operational, and executive audiences.
- Accountability, results orientation, and ability to learn from feedback.
- Sound judgment and analytical thinking to support independent, timely decision-making.
- Ability to communicate, influence, and escalate issues/decisions to support risk-based resolution.
Preferred skills:
- Experience engaging with Health Authorities during regulatory inspections.
- Prior experience within a regulatory authority.
Education / Experience:
- BS/BA in Biology/Sciences or related discipline plus 12+ years related experience; or
- MS/MA in Biology/Sciences or related discipline plus 10+ years related experience; or
- Equivalent combination of education and experience.
Travel:
- 30% travel required.
Benefits:
- Company-sponsored medical, dental, vision, and life insurance plans (plus potential discretionary annual bonus, stock-based long-term incentives, and paid time off).
Application instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.