Claire Kwan, B.s

Biography

 With over 20 years international experience in the biotechnology and pharmaceutical industries, specializing in quality assurance, compliance auditing and business development, Claire Kwan became part of the Pharma-GPS team in 2011. Her background includes basic laboratory research, manufacturing, quality assurance, regulatory affairs, and business development in entrepreneurial, biopharmaceutical settings in US, China, Taiwan, Canada and Europe. In previous positions at Carcinex Inc, Ms. Kwan established and managed cGMP compliant quality assurance systems for the production of in vitro diagnostics, and prepared 510(k) submissions. As Manager of Quality Assurance and Business Development at the USA and Asia divisions of Genelabs, Inc., Ms. Kwan designed and implemented quality systems. Her QA responsibilities also included performing internal and contract manufacturer compliance audits, conducting training programs, and participating in the design and construction of a GMP facility for manufacturing of parenterals. Ms. Kwan led successful joint venture evaluations/due diligence activities between Genelabs and Chinese/Taiwanese companies, including negotiating/developing contracts in the Chinese language and securing available government funding. Most recently, as Director of Quality Assurance and Regulatory Affairs at Centaur Pharmaceuticals, she was responsible for overseeing preclinical, manufacturing, and clinical QA, GLP/GMP/GCP compliance, regulatory affairs, and the submission of several successful INDs. She received her B.S. in Microbiology and MPH in Epidemiology and Laboratory Practice from the University of Michigan, and her MBA from Golden Gate University.

Research Interest

 GMP/GCP/GLP and quality assement