Director, GCP Inspection Readiness & Management
Gilead SciencesAbout the role
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 the Director, GCP Inspection Readiness & Management, at Gilead you will maintain a continuous, enterprise‑wide state of GCP inspection readiness across R&D clinical trials. The Director, GCP Inspection Readiness & Management serves as a lead sponsor representative and primary point‑of‑contact during regulatory inspections and provides strategic leadership to evolve Gilead’s global inspection management capabilities.
This position operates with significant autonomy and influence, partnering cross‑functionally across R&D, Quality, and external vendors to ensure inspection preparedness, execution excellence, and continuous improvement.
This position is based in Parsippany, NJ. Relocation assistance is not available, so local candidates are encouraged to apply.
Key Responsibilities & Outcomes
Enterprise GCP Inspection Leadership
Lead GCP inspection readiness, preparation, conduct, and closeout.
Coordinate unified, timely, and compliant responses to inspector requests and follow‑up actions.
Inspection Readiness Strategy & Governance
Develop and maintain short‑ and long‑range GCP inspection management strategies, infrastructure, and resource plans.
Establish standards and processes defining inspection <
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