Director, GVP Audits

Overview

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Based in either Stockley Park, UK or Cambridge, UK. Requires a 3‑day hybrid work structure in the office.

• Play a leadership role within Gilead’s R&D Quality Organization, driving audit excellence and ensuring global compliance across pharmacovigilance activities.
• Are responsible for the strategic execution of internal GVP audits and support the E‑System/Digital audit program.
• Oversee complex audits across broader R&D functions, external vendors, and critical pharmacovigilance work streams.
• GVP Audit Program Leadership
  • Accountable for the successful oversight and completion of a broad spectrum of GVP audit activities and deliverables across affiliates, partners, vendors and internal PV processes.
  • Responsible for driving the strategic execution and ongoing enhancement of the GVP Risk‑Based Audit Approach, encompassing long‑range and annual plans.
  • Serve as Process Owner for all related documentation, strategy materials, and risk assessments.
  • Lead internal R&D Quality audits for assigned R&D groups or locations.
  • Drive continuous improvement initiatives to enhance audit processes, systems, and standards, embedding a strong quality mindset across R&D.
  • Serve as a trusted advisor to senior stakeholders on GVP compliance and audit strategy.
• GVP Audit Operations
  • Act as a primary point‑of‑contact to assigned R&D groups and provide expert guidance on GVP regulatory requirements; relevant Gilead policies and procedures.
  • Execute the annual audit plan: plan, schedule, and conduct GVP audits with rigor and consistency.
  • Deliver high quality audit reports and ensure timely CAPA closure and effectiveness checks.
  • Collaborate with R&D Inspection Management (IM), Quality Business Partners (QBPs) and stakeholder SMEs to prepare PV partner audits from external PVA partners.
  • Lead and support risk assessment activities, in partnership with risk management teams.
  • Support the overall inspection readiness of the GVP Audit programs, and actively participate in regulatory inspections as required.
  • Oversee contractor auditors, ensuring quality and timely delivery of assigned audits and quality tasks.
  • Support the E‑Systems/Digital Audit program as needed, ensuring adherence to regulations and industry best practices.
  • Maintain an external network to assure current understanding of industry trends.
• Quality Management
  • Evaluate systems, processes, documentation to ensure ongoing compliance and continuous improvement.
  • Partner with the Audit Team leadership to implement an Effectiveness Check strategy, in partnership with GCP/GLP and E‑system Audit Heads for audit‑related CAPAs.
  • Stay current with evolving global PV regulations and guidance, translating requirements into actionable strategies.
  • Provide insights and updates for quality forums and management reviews.
• Training & Development
  • Develop and deliver GVP audit training for assigned R&D quality groups.
  • Develop and deliver targeted GVP audit and audit skill training, ensuring GVP Audits team is equipped with the knowledge and skills to maintain compliance and audit excellence.
  • Build strong relationships with key stakeholders, including contract auditors, functional leaders and teams to foster collaboration and knowledge sharing.
  • Create inclusion by knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
  • Develop talent by understanding the skills, experience, aspirations and potential of their employees and coaching them on current performance and future potential.
  • Empower teams by connecting them to the organization, aligning goals, purpose, and organizational objectives, and holding them to account.

• BA/…