Hongyang Li

Provide leadership for group QA of AsymBio, a fast growing CDMO for biological process development and manufacturing, ranging from CLD, mAb manufacturing, Antibody Drug Conjugation (ADC) and aseptic fill and finish (both liquid and lyophilizer). .

Provide leadership to the QA/QC organization at Suzhou Novartis Pharma Technology Co. Ltd, and ensure regulatory compliance and product quality at site.

Heading up the Asia Pacific regional Manufacturing Science and Technology organization of the Solids platform in Novartis Technical Operations, and responsible for the MS&T of seven plants of oral solid dosage form in the APAC cluster, including China, Japan, Singapore, Indonesia and Bangladesh. Providing leadership and supports for the seven sites in areas such as product portfolio and performance, product launches and tech transfers, technology application, process performance, process improvement, and process validations, including cleaning validations, in the region.

Responsible for pharmaceutical Manufacturing Science and Technology (MS&T) and packaging functions in the Local Market Manufacturing Platform of Novartis Technical Operation (NTO). The platform includes 13 sites across the globe in 10 countries such as Japan, China, Indonesia, Bangladesh, Brazil, Mexico, Russia, Algeria, Egypt, and South Africa. Duties include managing the MS&T teams in 13 local factories who are responsible for managing product portfolios, product transfers, process validations, cleaning validations, process improvements, and technical training, including network transformations within the platform.

Just started a new position and is fully responsible for quality management at TOT Biopharm, a CDMO for ADC product in Suzhou, China. TOT Biopharm offers an "All In One" solution to ADC products, with great technologies, facilities and teams.

Provided Quality leadership to a manufacturing site of 580 employees, including quality management systems and review, customer complaints, quality assurance, validation, device testing lab, metrology, document control, regulatory authority GMP inspections, batch release, non-conformity, change request, and CAPA system, supply chain and supplier quality management. Passed US FDA inspection at the site with "0" 483.

Worked as operations QA on the shopfloor of a human insulin filling plant, responsible for process development, GMP compliance, batch release, deviation handling, CAPA system, change control complaint handling etc. Later worked in Lilly Corporate Center and were responsible for Lilly Global Quality System, supported site implementation of global quality system procedures in many sites, including the US site, Mexico, Japan, Germany, France and China etc.

General management responsibility of a human insulin packaging & labeling facility, including construction, qualifying and validating equipment, supply chain setup, distribution, production, hiring and training employees, establishing GMP quality systems and managing Chinese authority GMP inspections.

Setup and managed a GMP QC lab for testing immunoassay diagnostics product kits, set up and transferred testing methods, recruited and coached lab technicians

Successfully registered a new B-carotene food supplement product and developed product specifications Managed contract manufacturing of the soft capsules, and launched the new product on time

Graduate program in Quality Manufacturing Management (QMM).

Diploma in management, 18 months executive management program at CEIBS, the first year of the program at CEIBS.