Hongyang Li

Quality Head, Novartis

Hongyang Li, currently Manufacturing Science & Technology (MS&T) Head for Ophthalmology & Local Market Manufacturing at Novartis Technical Operations, responsible for 6 sites in EU,Asia Pacific, Africa, and Russia. Previously Novartis Solids APAC MS&T Head, Quality Head at Novartis Suzhou plant, VP of Quality at Novo Nordisk’s Tianjin plant and Quality Lead at Eli Lilly in the United States. He has over 25-year experiences in pharmaceutical manufacturing, technology, and quality management, including over 5-year hands on experiences in the US. He has hosted and been involved in many GMP inspections, including two sites in China, under his quality leadership, passed the US FDA inspection with no 483. He holds a Bs. and Ms. in Biology from Nankai University, a Master degree in Manufacturing and Quality Management from Penn State University, USA, and a Diploma in Management from CEIBS. He is a Certified Quality Manager (CQM) and Certified Quality Auditor (CQA) from American Society for Quality (ASQ). He served as former Vice Chair of ISPE China Board (2015-2016) and also as a country representative of the Regulatory Affairs and Quality Advisory Board (RAQAB) of PDA (2012-2018). He also participated in drafting CFDA two GMP Appendixes (CSV & Validation) , Drug Data Management Practice, and ICH Q9 translation. He was also a certified QRM instructor in China by ISPE.


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