Associate Director – Quality Compliance and Audits

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide independent quality oversight for Gilead’s global manufacturing and supply network through GMP and GDP audits.

• Conduct and support global GMP and GDP audits of both internal manufacturing sites and external partners independently.

• Oversee the complete audit lifecycle, encompassing planning, scheduling, agenda creation, execution, reporting, and assessment of CAPA responses.

• Develop and implement risk-based audit strategies and agendas.

• Collaborate with Gilead stakeholders to collect background information, conduct risk assessments, and understand the business context for vendor audits.

• Enhance audit procedures, tools, templates, and training materials.

• Identify compliance deficiencies, quality risks, and systemic issues, escalating significant findings to management.

• Ensure uniformity and quality in the writing of audit observations, classification, risk assessment, and tracking of status.

• Conduct due diligence assessments and supplier qualification activities.

• Support metrics for the audit program, continuous improvement initiatives, performance objectives, timelines, and deliverables.

• Willingness to travel up to 50%.

⛳️ Requirements

• Bachelor's Degree and ten years of experience OR Master's Degree and eight years of experience OR PhD/PharmD and five years of experience.

• Relevant GMP/GDP audit experience within the pharmaceutical or biotechnology sectors.

• Demonstrated experience in the biotechnology and/or pharmaceutical industry.

• Proven track record in conducting independent GMP/GDP audits and contributing to or leading audits that require cross-functional teamwork.

• Comprehensive knowledge of GMP/GDP principles and global regulatory standards, including 21 CFR Parts 210 and 211, EU EudraLex Volume 4, ICH, ISO, and PIC/S.

• Familiarity with applicable compendial standards, such as USP and EP.

• Understanding of operations related to manufacturing, testing, and distribution across APIs, oral solid dosage forms, liquid formulations, biologics, aseptic fill/finish, packaging, warehousing, and distribution.

• Strong expertise in risk-based auditing methodologies and the complete audit lifecycle.

• Ability to interpret and apply changing regulatory expectations, industry trends, and quality standards.

• Exceptional written, verbal, and interpersonal communication skills.

• Strong organizational, leadership, and time-management capabilities.

• Capacity to work independently, handle competing priorities, and exercise sound professional judgment.

🏝️ Benefits

• Eligibility for discretionary annual bonuses.

• Eligibility for discretionary stock-based long-term incentives.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Reasonable accommodations for individuals protected under applicable disability laws.