Associate Director / Auditor, Quality Compliance and Audits

About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. The Associate Director / Auditor, a member of the Quality Compliance and Audits (QCA) group, is responsible for providing independent quality oversight of Gilead’s extensive global manufacturing and supply network by leading and supporting GMP and GDP audits. This role evaluates compliance with applicable global regulatory requirements, internal quality policies, and industry standards across internal manufacturing sites and a broad range of external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, spanning multiple modalities including small molecules, biologics, and medical devices/combination products.

Responsibilities

• Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, supporting clinical and commercial oral, parenteral, biologic drug products, and associated combination products and medical devices.
• Manage the end-to-end audit lifecycle, including audit planning and scheduling, agenda development, audit execution, audit report preparation and issuance, and assessment of responses and adequacy of proposed corrective and preventive actions (CAPAs).
• Develop and execute risk-based audit strategies and agendas that ensure appropriate scope, depth, and focus, incorporating relevant internal and external subject matter experts, as appropriate, to support effective and value-added audits.
• Partner cross-functionally with Gilead stakeholders to obtain relevant background information, risk assessments, and business context in advance of vendor audits, enhancing audit effectiveness and alignment with quality and organizational objectives.
• Contribute to the development, implementation, and continuous improvement of audit procedures, tools, templates, and training materials to promote consistency, quality, and efficiency within the audit program.
• Identify compliance gaps, quality risks, and systemic issues, and appropriately escalate significant or complex findings to management to support timely evaluation, prioritization, and resolution.
• Ensure consistency, clarity, and quality in audit observation writing, classification, risk assessment, and status tracking, in accordance with internal standards and regulatory expectations.
• Perform due diligence assessments and supplier qualification activities to support business expansion, onboarding of new suppliers, and adoption of new technologies and capabilities, as assigned.
• Support audit program metrics, continuous improvement initiatives, and established performance goals, while meeting defined timelines and deliverables.
• Uphold people leader accountabilities: create inclusion, develop talent, and empower teams by aligning goals, providing feedback, and removing barriers to success.

Requirements

• Bachelor's Degree and ten years' experience, OR Master's Degree and eight years' experience, OR PhD/PharmD and five years' experience.
• 50% travel required.

Qualifications

• Bachelor’s degree (BS or BA) in a relevant scientific or technical discipline with 10+ years of relevant GMP/GDP audit experience in the pharmaceutical or biotechnology industry; or
• Master’s degree (MS) in a relevant field with 8+ years of relevant GMP/GDP audit experience; or
• An equivalent combination of education, training, and experience.
• Demonstrated experience in the biotechnology and/or pharmaceutical industry.
• Proven GMP/GDP auditor with experience conducting independent audits and contributing to, and where appropriate leading, cross-functional and team-based audits.
• In-depth knowledge of GMP/GDP principles and global regulatory requirements, including but not limited to 21 CFR Parts 210 and 211, EU EudraLex Volume 4, and relevant international guidance (e.g., ICH, ISO, PIC/S), as well as applicable compendial standards (e.g., USP, EP).
• Comprehensive understanding of manufacturing, testing, and distribution operations across multiple dosage forms and technologies, including APIs, oral solid dosage forms, liquid formulations, biologics, aseptic fill/finish, primary and secondary packaging, and warehousing and distribution.
• Strong working knowledge of risk-based auditing methodologies and the full audit lifecycle, including planning, execution, reporting, and follow-up.
• Demonstrated ability to interpret and apply evolving regulatory expectations, industry trends, and quality standards to deliver high-quality, compliant audit outcomes.
• Excellent written, verbal, and interpersonal communication skills, with the ability to effectively communicate across technical, operational, and executive audiences.
• Strong organizational, leadership, and time-management skills, with the ability to work independently, manage competing priorities, and exercise sound professional judgment.

Pay

The salary range for this position is $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.