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Join to apply for the Director, GCP Audits role at Gilead Sciences

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. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.

Director, GCP Audits

Location: Cambridge or Stockley Park, UK

The Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead’s R&D Quality Organization, serving 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.

This position 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.
• Lead internal and external R&D quality audits for assigned R&D groups or locations.
• Provide matrix management and leadership to project teams.
• 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.
  
  

• 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.
• Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements.
• Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan.
• Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
• Lead/Support risk assessment activities, in partnership with risk program and SMEs.
• Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections.
• Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
• Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
• Provide accurate and thorough input and recommendations into resource allocation and budgets.
  
  

• Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
• Play a key role in preparing the assigned R&D groups for inspections or external reviews including 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.
  
  

• Develop and deliver on GCP training for assigned R&D groups ensuring teams are equipped with 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.
  
  

• PharmD/PhD w 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 successful 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.
  
  

• 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 appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
• Proven abilities to assume increasing scope and complexity, as 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, as evidenced by 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 with senior leadership, on key projects and deliveries supporting quality and compliance.
• Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of 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 skill and risk-based mindset.
• Proven track record of successful change management implementation across highly matrixed organizations.
• Ability to travel (up to 20%)
  
  

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Accounting/Auditing and Finance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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