Jim Lambert

Over his 20-year career in the biopharma industry (2003 to present), James has held global Director-level roles at leading firms like Shire, Baxter, Genentech-Roche, and Bayer. His expertise includes Quality Assurance, Regulatory Compliance, Technology Transfer, Quality Risk Management, Quality by Design, Six Sigma, and R&D. At Shire and Baxter, he managed teams in the U.S., Europe, and Asia, overseeing global Quality Assurance activities such as product release, investigations, CAPA, Technology Transfer, and regulatory submissions.

In 2017, James joined CAI as Director of Asia Operations, later supporting Pacific Southwest operations in the U.S. In 2022, he became the Southeast Asia Regional Director and is currently the Senior Director of CAI’s North America Northeast Region. James holds several patents in polymer chemistry and has a background in chemistry, economics, drug regulatory affairs, and health policy.