Senior Manager, Clinical Quality Assurance
Corcept Therapeutics · Redwood City, CA
Clinical OperationsCompany career page
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Role summary
Corcept Therapeutics seeks a Senior Manager of Clinical Quality Assurance to lead quality operations and compliance activities supporting clinical studies. The role involves audit planning, GCP audits, risk management, and regulatory oversight in a hybrid position based in Redwood City, California.
What they're looking for
- Bachelor's degree in science or related field, or equivalent experience
- 8+ years clinical research experience
- 2+ years clinical quality assurance experience preferred
- Understanding of quality systems supporting GCP activities
- Experience developing GCP processes aligned with industry best practices
- Experience leading complex investigations, root cause analysis, and CAPA
What you'll be doing
- Develop and manage audit plans using risk-based approach for assigned clinical studies
- Lead GCP audits including investigator sites, trial master files, and clinical study reports
- Serve as CQA lead representative providing compliance support throughout study lifecycle
- Support risk management activities and identify critical-to-quality factors for studies
- Lead critical investigations and support regulatory inspections and agency interactions
Privacy & handoff
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