Senior Director, Inspection Readiness

For our client, we are seeking a Senior Director, Inspection Readiness to join the team of a leader in the Pharmaceuticals & Biotech space.
This role will lead inspection readiness and GCP compliance efforts across clinical development programs, ensuring operational processes are prepared for regulatory scrutiny. You will partner closely with clinical operations, quality, and vendor teams to identify compliance gaps, strengthen readiness frameworks, and support accurate registration and reporting activities. The position is highly focused on risk-based oversight, remediation planning, and maintaining audit-ready practices that support successful clinical study execution.

Location:

Remote - US based candidates only, no visa sponsorship available
Compensation: $160,000 – $200,000 annually

• Provide leadership for inspection readiness and GCP compliance across clinical studies
• Develop a risk-based inspection readiness framework supporting clinical development
• Assess inspection readiness of operational processes and address compliance gaps
• Coordinate and oversee clinical trial registration and reporting requirements
• Monitor compliance metrics, inspection readiness reviews, and remediation actions

• Bachelor's degree in life sciences or a related field; advanced degree preferred
• 15+ years of clinical operations or related drug development experience, with a focus on inspection readiness
• Deep understanding of ICH-GCP, clinical trial regulations, and quality systems
• Experience preparing for regulatory inspections and mock audits
• Strong knowledge of clinical trial operations, including TMF and CRO/vendor oversight

• Medical and dental insurance
• Paid time off
• 401(k) with a generous company match

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.