Related skills
qa gcp audits gxp regulatoryπ Description
- Lead all QA activities for the company.
- Develop, implement, and maintain the Clinical QMS.
- Ensure GCP compliance and inspection readiness.
- Oversee CROs, labs, and vendors for GCP.
- Partner with Clinical Ops and Medical Affairs.
- Drive continuous QA improvement and risk mitigation.
π― Requirements
- Established GCP QA professional.
- Deep knowledge of QMS and GxP.
- Strong data analysis and communication skills.
- Experience auditing CROs, sites, and vendors.
- Track record with regulatory inspections.
- Lead cross-functional teams for compliance.
π Benefits
- Equal opportunity employer; inclusive culture.
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