Oncology Clinical Operations Compliance Lead
Exelixis
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Benefits offered by this job
Job summary
Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research in line with ICH GCP and local regulations. The role partners with QA and other functions to ensure inspection readiness, cross-study consistency, and escalation of operational quality issues.
A strong background in biopharma regulations and risk management is required. Responsibilities include developing risk management strategies, supporting CAPA processes, and monitoring CRO
Qualifications
- Bachelor's degree in related discipline with 11+ years of related experience; or
- Master's degree with 9+ years; or
- Doctoral degree with 5+ years; or equivalent combination of education and experience.
Responsibilities
- Support risk and issue management for compliant study delivery.
- Help create annual functional risk management plan for inspection readiness.
- Support CAPA owners with follow-up and closure.
- Assist CAPA data updates (late/near due/due later).
- Coordinate with QA and other R&D functions to escalate issues.
Skills
Education
Tools
Job description
Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research in line with ICH GCP and local regulations. The role partners with QA and other functions to ensure inspection readiness, cross-study consistency, and escalation of operational quality issues.
A strong background in biopharma regulations and risk management is required. Responsibilities include developing risk management strategies, supporting CAPA processes, and monitoring CRO
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