Associate Director – Quality Compliance and Audits

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🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $165.5k - $214.2k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $3.5M Post-IPO Debt - Gilead Sciences on 2024-11

Healthcare • Biotechnology • Pharmaceuticals

Gilead Sciences is a global biopharmaceutical company focused on researching, developing, and commercializing medicines primarily in virology, oncology, and inflammation. The company advances transformative therapies, runs extensive clinical programs and research collaborations, and supports access, global health, and community funding initiatives. Gilead also emphasizes corporate responsibility, sustainability, and inclusion while maintaining a broad pipeline of therapies and patient access programs.

📋 Description

• Provide independent quality oversight of Gilead’s global manufacturing and supply network through GMP and GDP audits • Independently conduct and support global GMP and GDP audits of internal manufacturing sites and external partners • Manage the end-to-end audit lifecycle, including planning, scheduling, agenda development, execution, reporting, and CAPA response assessment • Develop and execute risk-based audit strategies and agendas • Partner with Gilead stakeholders to gather background information, risk assessments, and business context for vendor audits • Improve audit procedures, tools, templates, and training materials • Identify compliance gaps, quality risks, and systemic issues and escalate significant findings to management • Ensure consistency and quality in audit observation writing, classification, risk assessment, and status tracking • Perform due diligence assessments and supplier qualification activities • Support audit program metrics, continuous improvement initiatives, performance goals, timelines, and deliverables • Travel up to 50%

🎯 Requirements

• Bachelor's Degree and ten years' experience OR Master's Degree and eight years' experience OR PhD/PharmD and five years' experience • Relevant GMP/GDP audit experience in the pharmaceutical or biotechnology industry • Demonstrated biotechnology and/or pharmaceutical industry experience • Proven experience conducting independent GMP/GDP audits and contributing to or leading cross-functional and team-based audits • In-depth knowledge of GMP/GDP principles and global regulatory requirements, including 21 CFR Parts 210 and 211, EU EudraLex Volume 4, ICH, ISO, and PIC/S • Knowledge of applicable compendial standards, including USP and EP • Understanding of manufacturing, testing, and distribution operations across APIs, oral solid dosage forms, liquid formulations, biologics, aseptic fill/finish, packaging, warehousing, and distribution • Strong working knowledge of risk-based auditing methodologies and the full audit lifecycle • Ability to interpret and apply evolving regulatory expectations, industry trends, and quality standards • Excellent written, verbal, and interpersonal communication skills • Strong organizational, leadership, and time-management skills • Ability to work independently, manage competing priorities, and exercise sound professional judgment

🏖️ Benefits

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentive eligibility • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance • Reasonable accommodation for individuals protected under applicable disability laws