According to press release issued by CMAB Biopharma, Mr Ye Shi Joins CMAB Biopharma As Head of Quality.
CMAB Biopharma (Suzhou) Inc. (“CMAB”), a dedicated biologics contract manufacturing and development organization (CDMO), today announced the appointment of Mr. Ye Shi as the Head of Quality. He will be responsible for the overall management of the quality system within CMAB.
Dr. Yongzhong Wang, CEO of CMAB said:” We are very pleased to welcome Mr. Ye Shi to CMAB. In the Chinese biopharmaceutical and CDMO industries, quality experts like Mr. Ye Shi are very rare. He has both front-line practical experience as well as success in managing an entire company quality system both at home and abroad. We believe that his leadership will greatly strengthen CMAB’s world-class CDMO quality system and provide our customers with more outstanding services.
Mr. Ye Shi said, “CMAB is the only pure-play CDMO in China that has passed the European QP audit. Therefore, I am very glad to join CMAB and look forward to working with the CMAB team to jointly promote high-quality innovation in biopharmaceuticals and further accelerate the launch of new drugs. Our firm commitment to quality will become a core value for customers and will allow CMAB to stand out in the market.”
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.
SOURCE : CMAB Biopharma Limited
