- Lead all Clinical Quality Assurance (QA) activities within the company.
- Develop, implement, and maintain all clinical quality assurance systems, processes, and procedures.
- Develop and track clinical quality metrics, approve deviations, and develop Corrective and Preventative Actions (CAPAs).
- Lead management review meetings and ensure continuous improvement.
- Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA).
- Qualify and audit CROs and clinical suppliers per internal SOPs.
- Monitor CRO performance and ensure compliance with GCP and company standards.
- Implement proactive risk identification and mitigation processes.
- Build and roll out QA training programs for internal staff and CRO partners.
GCPQuality Assurance