Associate Director, Clinical Quality Assurance

Role: Associate Director of Clinical Quality Assurance (CQA) overseeing GCP compliance and audit activities for clinical development programs at Corcept. Responsibilities: lead and manage the CQA team, develop audit plans using risk-based approaches, conduct and oversee GCP audits including investigator sites and study documents, support inspection readiness, and ensure regulatory compliance throughout clinical study lifecycles. Also includes process improvement, risk management, and training initiatives. Qualifications: BA/BS in biological sciences or related field; 10+ years of experience in clinical quality systems and GCP audits within pharmaceutical or biotech settings, with expertise in developing SOPs and preparing for regulatory inspections. Skills: strong GCP audit capabilities, knowledge of clinical quality systems, proficiency in Microsoft Office. High-value specifics: experience supporting clinical studies in phases 1-3, with a focus on GCP compliance, inspection readiness, and quality system development. Work setup: hybrid role requiring at least 3 days on-site; travel required.