Shawn Gould is Director of Compliance with Johnson & Johnson’s Regulatory Compliance group. He currently holds responsibilities in the Pharma Segment overseeing compliance issues regarding large molecule products as well as serving on Proactive Compliance and PV Lifecycle Implementation teams. Shawn also served in the US Food and Drug Administration’s Office of Compliance where he worked on the pre-approval process for new and generic drugs with special emphasis on applications involving QbD and PAT concepts. He also served on FDA working groups relating to Quality Systems, the PAI process, Strategic Planning, and Lean Operations within the agency.
Over his nearly 20 years in pharmaceuticals, Gould has held roles in development, manufacturing, quality, and validation for several companies within the industry including biopharmaceutical, blood plasma fractionation, and topical/medical device firms. Previous major project assignments have encompassed fermentation, downstream protein purification, sterile filtration, aseptic processing, liquid/cream/lotion filling, facility design, process simulations, and statistical evaluation/modeling. Gould graduated from the University of Toledo with a Bachelors Degree in chemical engineering followed by his Masters Degree in chemical engineering from Washington University in St. Louis, Missouri.