James Morris, BA Biology, MBA NSF Health Sciences

Jim has significant experience in plant operations and has spent over 25 years in the industry with Pfizer as well as Cilag AG and MassBiologics in the US and Europe. He has held positions as Deputy Director QA/QC and Regulatory Affairs at Mass Biologics in Boston, Director of QA/QC for the Biologics business unit of Cilag AG in Switzerland, and a number of Quality Assurance and Manufacturing roles with Pfizer, Inc. over a 16 year timeframe culminating as the head of Quality Assurance for Pfizer in Latina, Italy.

Areas of focus include Aseptic Operations, Quality Management Systems, specifically in the areas of deviations / CAPA management and change control. Jim's course and speaking engagements are in the areas of Human Error Reduction, Quality Management Systems, and Emerging Markets. Jim has been working in a consulting capacity since 2008.