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% High Value: clinical and nonclinical audits GCP/GLP/GCLP compliance vendor oversight inspection readiness regulatory support Work Setup: primarily on-site with domestic and international travel. #J-18808-Ljbffr Korro Bio, Inc.