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John Henchion

Global Director, Quality, Compliance, & Regulatory

John has more than 23 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John is a Quality Systems SME. He has in-depth understanding of tech transfer, supply chain qualification, aseptic processing, biotechnology products (MABs and other therapeutic proteins), oral solid dosage, liquid fill, lyophilization, sterilization, bulk chemical API and medical devices. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP/ISO compliance auditing of manufacturing facilities and supply chain. He is familiar with implementation of Lean principles and tools, Kaizen events, root cause analysis, visual workplace, standardized work and process mapping of supply chain.