Associate Director, Clinical Quality Assurance
Corcept Therapeutics
Associate Director of Clinical Quality Assurance at a biopharmaceutical company focused on cortisol modulation therapies. Lead CQA operations and compliance activities across clinical development programs while managing team members and supporting study lifecycle oversight.
Responsibilities
- Direct clinical quality assurance activities and lead team members on assigned clinical programs
- Develop and manage audit plans using risk-based approaches for compliance oversight
- Conduct and oversee GCP audits of investigator sites, trial documents, and clinical study reports
- Support regulatory inspections and manage inspection readiness activities
- Lead investigations into clinical non-compliance issues and support continuous quality system improvements
Requirements
- Clinical Quality Assurance expertise with demonstrated leadership experience
- Strong knowledge of Good Clinical Practice (GCP) and regulatory compliance requirements
- Experience conducting and managing clinical audits and inspections
- Proficiency in risk-based quality management and process development
- Background in clinical trial oversight and Trial Master File management
Vacancy posted 8 days ago
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