Manager, Clinical Quality Assurance
Corcept TherapeuticsRedwood City, California, United States
Posted October 29, 2025
154100 - 181300 USD year
Full Time
About the Company
Corcept Therapeutics is a pioneering biotechnology company dedicated to unlocking the potential of cortisol modulation. With over 25 years of expertise, they have developed more than 1,000 selective cortisol modulators and secured FDA approval for the first treatment for hypercortisolism (Cushing’s syndrome). The company continues to drive innovation across endocrinology, oncology, metabolism, and neurology through ongoing research and development.
Job Description
Corcept is a research and development company focused on cortisol modulation, seeking a Manager of Clinical Quality Assurance to support the success of clinical studies. This hybrid role involves leading clinical quality audits, ensuring regulatory compliance, and improving GCP systems. The role requires strong clinical research experience and expertise in quality systems.
Requirements
- Lead/manage Good Clinical Practice (GCP) audits
- Serve as a QA representative and support clinical study teams
- Participate in clinical study document review and approval
- Manage study-specific Clinical Study Audit Plans (CSAP) compliance
- Lead continuous improvement of the Clinical Quality Management Systems (CQMS)
- Support inspection readiness activities
- Support clinical inspections
- Provide cross-training development opportunities
- Maintain knowledge of agency and industry trends
