Associate Director / Auditor, Quality Compliance and Audits
Gilead Sciences
August 18, 2026
Remote friendly (United States)
United States
Operations
Job Description
Associate Director / Auditor (Quality Compliance and Audits - QCA): Provide independent quality oversight of GMP/GDP compliance across Gilead’s global manufacturing and supply network by leading and supporting audits of internal sites and external partners.
Key Responsibilities
- Independently conduct and support global GMP and GDP audits (internal sites; contract manufacturers, labs, suppliers, distributors, and other third parties) for clinical/commercial drug products and associated combination products and medical devices.
- Manage the full audit lifecycle: planning/scheduling, agendas, execution, report issuance, and CAPA response adequacy.
- Create and execute risk-based audit strategies and scopes, engaging internal/external SMEs as needed.
- Partner cross-functionally to gather background, risk assessments, and business context before vendor audits.
- Improve audit procedures/tools/templates/training for consistency and efficiency.
- Identify compliance gaps/quality risks/systemic issues; escalate significant findings to management.
- Ensure high-quality audit observations, classification, risk assessment, and status tracking.
- Perform due diligence/supplier qualification as assigned.
- Support audit metrics, continuous improvement, and performance goals; meet timelines. 50% travel required.
Basic Qualifications
- Bachelor’s + 10 years OR Master’s + 8 years OR PhD/PharmD + 5 years.
Preferred Qualifications / Skills
- 10+ years (BS/BA) or 8+ years (MS) relevant GMP/GDP audit experience in pharma/biotech; demonstrated biotech/pharma experience.
- Experience conducting independent and cross-functional/team audits.
- Strong knowledge of GMP/GDP and global regulations (e.g., 21 CFR 210/211, EU EudraLex Vol 4; ICH/ISO/PIC/S) and standards (USP/EP).
- Understanding of manufacturing/testing/distribution across multiple modalities/dosage forms and warehousing.
- Risk-based auditing and full audit lifecycle expertise; strong communication and organization.
People Leader Accountabilities
- Create inclusion, develop talent, empower teams.
Compensation & Benefits (as stated)
- Salary range: $165,495.00–$214,170.00; may include bonus/stock incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- For current employees/contractors: Apply via the Internal Career Opportunities portal in Workday.
Associate Director / Auditor (Quality Compliance and Audits - QCA): Provide independent quality oversight of GMP/GDP compliance across Gilead’s global manufacturing and supply network by leading and supporting audits of internal sites and external partners.
Key Responsibilities
- Independently conduct and support global GMP and GDP audits (internal sites; contract manufacturers, labs, suppliers, distributors, and other third parties) for clinical/commercial drug products and associated combination products and medical devices.
- Manage the full audit lifecycle: planning/scheduling, agendas, execution, report issuance, and CAPA response adequacy.
- Create and execute risk-based audit strategies and scopes, engaging internal/external SMEs as needed.
- Partner cross-functionally to gather background, risk assessments, and business context before vendor audits.
- Improve audit procedures/tools/templates/training for consistency and efficiency.
- Identify compliance gaps/quality risks/systemic issues; escalate significant findings to management.
- Ensure high-quality audit observations, classification, risk assessment, and status tracking.
- Perform due diligence/supplier qualification as assigned.
- Support audit metrics, continuous improvement, and performance goals; meet timelines. 50% travel required.
Basic Qualifications
- Bachelor’s + 10 years OR Master’s + 8 years OR PhD/PharmD + 5 years.
Preferred Qualifications / Skills
- 10+ years (BS/BA) or 8+ years (MS) relevant GMP/GDP audit experience in pharma/biotech; demonstrated biotech/pharma experience.
- Experience conducting independent and cross-functional/team audits.
- Strong knowledge of GMP/GDP and global regulations (e.g., 21 CFR 210/211, EU EudraLex Vol 4; ICH/ISO/PIC/S) and standards (USP/EP).
- Understanding of manufacturing/testing/distribution across multiple modalities/dosage forms and warehousing.
- Risk-based auditing and full audit lifecycle expertise; strong communication and organization.
People Leader Accountabilities
- Create inclusion, develop talent, empower teams.
Compensation & Benefits (as stated)
- Salary range: $165,495.00–$214,170.00; may include bonus/stock incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- For current employees/contractors: Apply via the Internal Career Opportunities portal in Workday.