Associate Director, Clinical Quality Assurance

Role: Associate Director, Clinical QA, providing hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards. Responsibilities: lead audits of CROs, laboratories, and investigator sites domestically and internationally; manage clinical quality events, deviations, and CAPAs; review key study documentation; support vendor qualification, oversight, and inspection readiness; develop and maintain quality systems and SOPs; track audit findings and quality metrics; assist in regulatory submissions and agency inspections. Requirements: bachelor's in Life Sciences or related field; 10+ years in biopharma/clinical research, with at least 7 years in GCP/QA roles; proven experience leading vendor and site audits, including GLP nonclinical facilities; working knowledge of ICH E6 (including E6 R3), 21 CFR Parts 11, 50, 54, 56, 58, 312, and EU Clinical Trials Regulation; ability to travel up to 20%. HighValue: clinical and nonclinical audits, GCP/GLP/GCLP compliance, vendor oversight, inspection readiness, regulatory support. WorkSetup: primarily on-site with domestic and international travel.