Director, GCP Inspection Readiness & Management
Gilead Sciences
July 01, 2026
On-site
Parsippany, NJ
Clinical Research and Development
Director, GCP Inspection Readiness & Management
Key Responsibilities & Outcomes
- Lead GCP inspection readiness, preparation, conduct, and closeout.
- Coordinate unified, timely, and compliant responses to inspector requests and follow-up actions.
- Develop and maintain short- and long-range GCP inspection management strategies, infrastructure, and resource plans.
- Establish inspection readiness standards/processes and integrate lessons learned into continuous readiness.
- Conduct horizon scanning and integrate regulatory intelligence to proactively assess and mitigate inspection risks.
- 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.
- Define, maintain, and analyze GCP inspection readiness KPIs (readiness scorecards, TMF quality signals, response timeliness, CAPA cycle time).
- Contribute inspection metrics/trend analysis into Quality Management Reviews.
- Drive Veeva QMS record development for inspection findings, action plans, and commitment follow-up.
- 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/inspection readiness.
Required/Preferred Qualifications & Skills
- PharmD or PhD with 8+ years; OR MA/MS/MBA with 10+ years; OR BA/BS with 12+ years relevant experience.
- Expert knowledge of GCP, drug development process, and TMF/eTMF requirements.
- Strong knowledge of GxP Quality Management Systems, policies, and procedures.
- Demonstrated ability to manage large-scale, complex, time-sensitive initiatives; influence without authority.
- Significant biopharma experience advising on quality/compliance, evolving regulations, risk minimization/mitigation, and continuous improvement.
- Significant experience in GCP inspection management (front-room/back-room roles).
- Preferred: experience with global health authorities; external consortiums/trade associations; scaling inspection management infrastructure in global R&D; coaching/mentoring quality/inspection leaders; contributing to resourcing/budget planning.
Benefits (if provided)
- May be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Position is based in Parsippany, NJ; relocation assistance is not available—local candidates encouraged to apply.
Key Responsibilities & Outcomes
- Lead GCP inspection readiness, preparation, conduct, and closeout.
- Coordinate unified, timely, and compliant responses to inspector requests and follow-up actions.
- Develop and maintain short- and long-range GCP inspection management strategies, infrastructure, and resource plans.
- Establish inspection readiness standards/processes and integrate lessons learned into continuous readiness.
- Conduct horizon scanning and integrate regulatory intelligence to proactively assess and mitigate inspection risks.
- 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.
- Define, maintain, and analyze GCP inspection readiness KPIs (readiness scorecards, TMF quality signals, response timeliness, CAPA cycle time).
- Contribute inspection metrics/trend analysis into Quality Management Reviews.
- Drive Veeva QMS record development for inspection findings, action plans, and commitment follow-up.
- 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/inspection readiness.
Required/Preferred Qualifications & Skills
- PharmD or PhD with 8+ years; OR MA/MS/MBA with 10+ years; OR BA/BS with 12+ years relevant experience.
- Expert knowledge of GCP, drug development process, and TMF/eTMF requirements.
- Strong knowledge of GxP Quality Management Systems, policies, and procedures.
- Demonstrated ability to manage large-scale, complex, time-sensitive initiatives; influence without authority.
- Significant biopharma experience advising on quality/compliance, evolving regulations, risk minimization/mitigation, and continuous improvement.
- Significant experience in GCP inspection management (front-room/back-room roles).
- Preferred: experience with global health authorities; external consortiums/trade associations; scaling inspection management infrastructure in global R&D; coaching/mentoring quality/inspection leaders; contributing to resourcing/budget planning.
Benefits (if provided)
- May be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Position is based in Parsippany, NJ; relocation assistance is not available—local candidates encouraged to apply.