Director, GCP Inspection Readiness & Management

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 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 Quality stakeholders 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 & Project Leadership

• Develop and deliver GCP 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.

• Strong analytical, communication, and organizational skills.

• Ability to travel when required.

BASIC QUALIFICATIONS

• PharmD or PhD with 8+ years of relevant experience; OR

• MA/MS/MBA with 10+ years of relevant experience; OR

• BA/BS with 12+ years of relevant experience.

PREFERRED QUALIFICATIONS

• Experience working for or directly with a global health authority.

• Experience representing organizations in external consortiums, trade associations, or industry working groups.

• Demonstrated success developing or scaling inspection management infrastructure in a global R&D environment.

• Strong coaching and mentoring capabilities with experience developing quality or inspection leaders.

• Experience contributing to resourcing and budget planning for quality or inspection management functions.