Ye Shi

Over the last 30 years, Mr. Ye Shi has worked in biopharmaceutical companies in both China and the United States and promoted their quality management towards a world-class level. Before joining CMAB, he served as the Deputy General Manager and Quality Assurance Director at QILU Pharmaceutical Co., Ltd. There, he successfully led the team to pass the Pre-inspection approval (PAI) of antibody drugs by the Chinese Centre for Drug Evaluation (CDE), which subsequently successfully entered commercialization. Additionally, he led the quality team to successfully pass the European QP audit, laying the foundation for clinical trials in the EU and internationally. Furthermore, he has served as the Corporate QA and Compliance Director of the PDI Company in the United States, guiding the quality team of a Chinese CMO quality unit through site inspections by FDA and Health Canada. Moreover, he has previously served as Site Quality Head and Quality Assurance Director at Immunomedics in the United States, where he oversaw the quality systems of two biopharmaceutical plants, including plant design, planning, construction, verification, and formal operations. Previously, Mr. Ye Shi worked at Wyeth Lederle, The Validation Group, and Sino-American Shanghai Squibb Pharmaceuticals.