Senior Manager, Clinical Quality Assurance

Role: Senior Manager of Clinical Quality Assurance (CQA) supporting Corcept's clinical studies, primarily focused on ensuring GCP compliance across various trial activities. Responsibilities include developing risk-based audit plans, leading GCP audits of investigator sites and study documentation, managing quality investigations, supporting inspection readiness, and providing compliance oversight throughout the study lifecycle. The role also involves assessing service provider changes, reviewing clinical documents, and mentoring junior QA team members. Requirements: BS/BA in science or related field, 8+ years in clinical research with at least 2 years in CQA, deep understanding of GCP quality systems, experience leading quality investigations and root cause analyses, and familiarity with GCP processes. Preferred skills include developing GCP procedures, managing regulatory inspections, and handling complex quality issues. HighValue: experience in GCP auditing, clinical study oversight, risk management, and investigator site inspection support. WorkSetup: hybrid model, onsite at least 3 days/week, some travel.