Overview
The Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead’s R&D Quality Organization, acting as the primary point of contact for assigned R&D groups across designated geographic regions and therapeutic areas. This position is responsible for executing internal and investigator site GCP audits, in support of the R&D Quality Annual Audit plan.
Location: Cambridge or Stockley Park, UK.
This role requires close collaboration with cross-functional stakeholders, including R&D Clinical Quality Business Partners (CQBPs), the Quality Governance, Risk, Audit & Analytics (GRA&A) team, and other relevant departments. The Director is instrumental in proactively identifying, evaluating, and mitigating clinical compliance risks while supporting the overall compliance of clinical processes and portfolio. In partnership with GVP and E-System/Digital Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.
Reporting to the Head of GCP/GLP Audits, the Director contributes to the strategic development and operational execution of the GCP audit function. Responsibilities include developing audit tools and procedures, resource planning, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPA status.
Beyond auditing, the Director supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This role is vital to maintaining global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high-quality audits, supporting Gilead’s mission to advance transformative therapies.
Primary Responsibilities
* GCP Audit Program Leadership: Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions.
* GCP Audit Operations: Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities.
* GCP Audit Program Management: Provide matrix management and leadership to project teams.
* Quality Improvement: Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture.
Quality Management
* Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
* Prepare assigned R&D groups for inspections or external reviews, ensuring alignment with Gilead business needs and regulatory requirements.
* Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs.
* Stay current with evolving global clinical regulations and guidance.
* Support the development of GCP Audit material/insights for quality forums and management reviews.
Training & Development
* Develop and deliver GCP training for assigned R&D groups to ensure teams have the knowledge and skills to maintain compliance and audit excellence.
* Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing, and continuous improvement initiatives.
Qualifications
* PharmD/PhD with relevant experience
* MA/MS/MBA with relevant experience
* BA/BS with relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields.
* Proficiency in clinical regulatory requirements (Global) is a must.
* Expert-level experience working with GCP processes and systems is required.
* Proficient in GxP Auditing with a proven track record of leading clinical/investigator site audits.
* Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
* Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
* Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation.
* Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
* Certification as a Quality Auditor is preferred.
* Rest Of World Education & Experience: BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field. Extensive experience leading GCP audits in the biopharma or related industry.
Knowledge & Other Requirements
* Expert knowledge of the drug development process and GCP, including global regulations (FDA, EMA, ICH) and their application to cross-functional clinical development.
* Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
* Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GCP.
* Proven effectiveness in making independent decisions for relatively complex projects or issues, as evidenced by past decision-making track record.
* Proven abilities to assume increasing scope and complexity, evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
* Advanced business knowledge and analytical skills, with strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
* Track record of successful interaction and collaboration with other functions and senior leadership on key projects and deliveries supporting quality and compliance.
* Demonstrates ability to execute against strategic and tactical objectives provided by senior leaders both within Quality and outside the function.
* Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
* Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions.
* Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
* Strong critical and strategic thinking with a risk-based mindset.
* Proven track record of successful change management implementation across highly matrixed organizations.
* Ability to travel (up to 20%).
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead’s focus areas include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
EEO
Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit and employ the most qualified persons for positions throughout the Company. Except where prohibited by applicable law, all employment actions are administered on a non-discriminatory basis. Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
How to apply
Please apply via the Internal Career Opportunities portal in Workday if you are a current Gilead employee.
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