Director, GCP Inspection Readiness & Management (United States - New Jersey - Parsippany)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

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   G CP   inspection   readi ness,   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   readiness and integrate lessons learned into continuous readiness practices.  

• Conduct horizon scanning and integrate regulatory intelligence to proactively assess and mitigate inspection risks.  

TMF/eTMF & Vendor Readiness Oversight  

• Own TMF/eTMF inspection readiness expectations and lead periodic health checks.  

• Lead   risk ‑ based   readiness assessments and inspection drills for key clinical vendors (e.g., CROs, labs,   eCOA , IRT).  

• Partner   with   R &D Q uality s take holde rs   to ensure sustained readiness.  

Metrics, Insights & Continuous Improvement  

• Define,   maintain , and analyze GCP inspection readiness KPIs (e.g., readiness scorecards, TMF quality signals, response timeliness, CAPA cycle time).  

• Contribute   inspection   metrics and trend analysis into Quality Management Reviews.  

• Drive Veeva QMS record development for inspection findings, action plans, and commitment   follow ‑ up .  

Training, Change Management &  Pro ject   Leadership  

• Develop and deliver   GC P   inspection ‑ specific   training, playbooks, and readiness frameworks.  

• Provide matrixed leadership to inspection teams and Subject Matter Experts.  

• Foster a culture of quality and inspection readiness across Gilead R&D and vendor partners.  

• Significant experience   advising   biopharma business functions on quality and compliance requirements, evolving regulations, risk minimization, mitigation, and continuous improvement.  

• Significant experience   in GCP inspection management in the biopharma industry, including key   front ‑ room   and/or   back ‑ room   inspection roles.  

• Demonstrated ability to manage   large ‑ scale , complex, and   time ‑ sensitive   initiatives.  

• Proven experience leading   cross ‑ functional   process improvement initiatives with measurable outcomes.  

• Expert knowledge of GCP, the drug development process, and TMF/eTMF requirements.  

• Strong knowledge of   GxP   Quality Management Systems, policies, and procedures.  

• Demonstrated leadership presence with the ability to influence without authority. <]]>