Associate Director – Auditor, Quality Compliance and Audits

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $165.5k - $214.2k / year

⏰ Full Time

🟠 Senior

🔎 Auditor

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 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 • Incorporate relevant internal and external subject matter experts into audits • Partner cross-functionally with stakeholders to gather background information, risk assessments, and business context for vendor audits • Develop, implement, and continuously improve audit procedures, tools, templates, and training materials • Identify compliance gaps, quality risks, and systemic issues, escalating significant or complex findings to management • Ensure quality and consistency of audit observations, classifications, risk assessments, and status tracking • Perform due diligence assessments and supplier qualification activities • Support audit program metrics, continuous improvement initiatives, performance goals, timelines, and deliverables • Travel approximately 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 experience in the pharmaceutical or biotechnology industry • Demonstrated biotechnology and/or pharmaceutical industry experience • Proven GMP/GDP auditor experience conducting independent 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 • Ability to travel 50%

🏖️ Benefits

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentives eligibility may vary based on role • 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 and rehabilitation laws