Senior Director, Inspection Readiness
Absci · Remote
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Role summary
Absci seeks a Senior Director of Inspection Readiness to lead clinical operations compliance and inspection preparedness across its development portfolio. This role provides sponsor-level oversight of GCP compliance, operational processes, and regulatory adherence, reporting to the SVP of Global Clinical Operations.
What they're looking for
- Senior-level clinical operations experience with inspection readiness and GCP compliance expertise
- Demonstrated experience leading cross-functional teams in regulated clinical development environments
- Knowledge of clinical trial documentation, data integrity, and regulatory inspection standards
- Experience developing risk-based compliance frameworks and remediation processes
- Familiarity with clinical trial registration and results-reporting requirements (ClinicalTrials.gov)
- Strong project management and issue tracking capabilities in clinical development
What you'll be doing
- Provide sponsor-level leadership for inspection readiness and GCP compliance across clinical studies and programs
- Develop and maintain risk-based inspection readiness framework supporting the clinical portfolio
- Assess clinical studies for readiness gaps in documentation, oversight, data integrity, and regulatory adherence
- Coordinate cross-functional remediation efforts with Clinical Operations, Quality, Regulatory, and Development functions
- Establish and oversee clinical trial registration, results-reporting, and training compliance processes
Privacy & handoff
This role links to Absci's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.