Overview

Director, GCP AuditsLocation: Cambridge or Stockley Park, UKThe Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead’s RandD Quality Organization. This position is the primary point of contact for assigned RandD groups across designated geographic regions and therapeutic areas, responsible for executing internal and investigator site GCP audits in support of the RandD Quality Annual Audit plan. The role requires collaboration with cross-functional stakeholders and proactivity in identifying, evaluating, and mitigating clinical compliance risks while supporting the overall compliance of clinical processes and portfolio. Reporting to the Head of GCP/GLP Audits, the Director contributes to strategic development and operational execution of the GCP audit function.Beyond auditing, the Director supports regulatory inspections, readiness, and partners with the RandD Quality Extended Leadership team to build quality capabilities and drive process improvements and transparency. This role is vital to maintaining global compliance, reinforcing audit excellence, and ensuring the delivery of high-quality audits to advance transformative therapies.Primary Responsibilities

GCP Audit Program Leadership: oversee a broad spectrum of GCP audit activities across large sites, countries, or regions; lead internal and external audits for assigned RandD groups or locations; provide matrix leadership and drive continuous improvements in RandD quality processes, systems, and standards.GCP Audit Operations: act as primary point of contact for assigned RandD groups; advise on GCP regulatory requirements and applicable policies; evaluate SOPs and data for regulatory compliance; execute the strategic audit plan; plan, schedule, and conduct audits; prepare high-quality audit reports and follow up on CAPAs; lead risk assessment activities; support inspection readiness; oversee contractor auditors; track resources and ensure regulatory timeline compliance; contribute to budget/resource planning.Quality Management: advise on systems, processes, documentation, and CAPAs to ensure ongoing compliance; prepare groups for inspections; support implementation of an Effectiveness Check strategy; stay current with global clinical regulations; contribute to quality forums and management reviews.Training and Development: develop and deliver GCP training for assigned RandD groups; build relationships with stakeholders to facilitate training and continuous improvement initiatives.Qualifications

BASIC QUALIFICATION: PharmD/PhD with relevant experience; MA/MS/MBA with relevant experience; BA/BS with relevant experience or advanced degree in life sciences with significant quality/compliance experience; proficiency in global regulatory requirements; expert-level GCP processes and systems experience; proficiency in GxP auditing; cross-functional project experience; leadership of quality/compliance projects; experience with Lean Six Sigma is preferred; Quality Auditor certification preferred.REST OF WORLD: BA/BS or advanced degree in life sciences with significant biopharma quality/compliance experience; extensive experience leading GCP audits; knowledge of drug development, GCP, FDA/EMA/ICH regulations; ability to travel up to 20%.About Gilead RandD Quality

Gilead RandD Quality is a collaborative, inclusive group of quality professionals dedicated to delivering life-saving therapies for unmet needs. We value diverse perspectives and strong leadership, aiming to empower each team member to contribute to our mission.About Gilead

Gilead Sciences, Inc. discovers, develops, and commercializes innovative medicines across HIV/AIDS, liver diseases, cancer, inflammation, and respiratory and cardiovascular conditions. We are a mission-driven biopharmaceutical company focused on creating possible for patients worldwide.Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries to recruit and employ the most qualified persons for positions throughout the Company. Employment actions are administered on a non-discriminatory basis, without regard to protected characteristics or prohibited grounds as defined by applicable laws. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

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