Associate Director – Auditor, Quality Compliance and Audits

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

📋 Description

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

• Independently carry out and assist with global GMP and GDP audits of both internal manufacturing facilities and external partners.

• Oversee the complete audit lifecycle, which includes planning, scheduling, agenda creation, execution, reporting, and evaluating CAPA responses.

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

• Integrate relevant internal and external subject matter experts into the audit process.

• Collaborate cross-functionally with stakeholders to collect background information, conduct risk assessments, and provide business context for vendor audits.

• Create, implement, and continually enhance audit procedures, tools, templates, and training resources.

• Detect compliance gaps, quality risks, and systemic issues, escalating significant or complex findings to management.

• Ensure the quality and uniformity of audit observations, classifications, risk assessments, and status tracking.

• Carry out due diligence assessments and supplier qualification processes.

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

• Engage in travel approximately 50% of the time.

⛳️ Requirements

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

• Relevant experience within the pharmaceutical or biotechnology sectors.

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

• Established GMP/GDP auditor experience conducting independent audits and either contributing to or leading cross-functional team audits.

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

• Familiarity with applicable compendial standards, including USP and EP.

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

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

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

• Exceptional written, verbal, and interpersonal communication skills.

• Strong organizational, leadership, and time management abilities.

• Capability to work independently, manage competing priorities, and exercise sound professional judgment.

• Willingness to travel 50% of the time.

🏝️ Benefits

• Eligibility for discretionary annual bonuses.

• Eligibility for discretionary stock-based long-term incentives, which may vary based on the role.

• 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 and rehabilitation laws.