Senior Manager, Clinical Quality Assurance

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.

Responsibilities

• 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

Requirements

• 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