Director, GVP Audits

Overview

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

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.

As a Director, GVP Audits
, at Gilead you will...

• 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 supports the E-System/Digital audit program
• Oversee complex audits across broader R&D functions, external vendors, and critical pharmacovigilance work streams and processes
• We are seeking a candidate to sit in Parsippany, NJ / Stockley Park, UK / Cambridge, UK. Ideally, candidate is local to site.

This position requires strong collaboration with cross-functional stakeholders, including R&D Quality Business Partners (QBPs), Patient Safety, and QPPV. The Director will work with stakeholders to proactively identify, evaluate, and mitigate pharmacovigilance compliance risks. In addition, the Director will be responsible for the GVP Audit Master Index and the strategic and operational activities of the GVP Risk-based Audit process (Annual and Long Range Plans).

Reporting to the Head of GVP Audits, the Director contributes to the vision, strategy, and operational delivery of the GVP Audits function. Responsibilities include developing robust audit tools and procedures, optimizing resource planning, ensuring corrective and preventive actions (CAPAs) effectiveness, and providing transparent updates through quality governance forums.

Beyond auditing, this role supports regulatory inspections and R&D inspection readiness, and partners with the R&D Quality Extended Leadership team to build quality capabilities, drive process improvements and foster a culture of compliance and continuous improvement. The Director ensures audit excellence, and consistency, reinforcing Gilead’s mission to advance transformative therapies, with uncompromising quality and compliance.

• 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. Serves 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…