Roger Ouimet CAI

Roger is an experienced Program Manager and Owner Project Manager, with extensive background in implementing small to large-scale expansion capital projects in Formulation, Filling, Packaging and QC Labs, as well as across entire facilities for New Product Introduction and the associated Commissioning, Qualification, and Validation (CQV) deliverables and processes to support planning and execution. Additionally, Roger spent 30 years Active and Reserve in the US Navy, filling seven Command and additional unit, staff and global leadership roles. As a Principal Consultant and Interim Director, Program and Project Management, he has launched QC Applications, Manufacturing Execution System (MES) upgrades, and a vial powder filling isolator product and process. He also delivered a new Project Management Office (PMO) and Operational Excellence programs for his clients. An active member of several PDA Interest Groups, Roger contributed comments to the FDA and EMA on their draft guidance papers on AI in Drug Development and Drug Manufacturing, and the Department of Homeland Defense’s draft law on Cyber Incident Reporting for Covered Entities.