Ms. Hong’s regulatory compliance experience with multinational CRO and CMO organizations is augmented with over 15 years of Quality Systems work for biotech companies ranging from midsize to market dominating. She has assisted clients develop products targeting infectious and immune-based diseases. From preclinical animal studies through human clinical trials and to commercial drug-device development activities, her experience spans the full regulatory life cycle. Her Quality Assurance experience touches nearly every quality subsystem: document control; deviation, CAPA, change control program, PQA; QC; raw materials management; product release testing; supplier quality; supplier and product complaints; validation program; facilities operations; and manufacturing operations (from engineering run through fill/finish and to packaging/labeling). Ms. Hong has managed and supported domestic and international audits, having performed audits for PAI, Regulatory Health Authorities, QP, Client, ISO, and Supplier audits. Ms. Hong has a Master’s degree in Regulatory Affairs in Drugs, Biologics and Medical Devices with a concentration in regulatory compliance from Northeastern University. Fluent in Korean, she has translated for clients and for MOHW audits. Prior to QA she has worked in QC and in toxicology.