I am an accomplished bio-pharmaceutical professional with experience in Quality, Regulatory Affairs, Operations, and Project Management. I have served as a Senior Quality Product Owner for two products and in this role I was a product steward as the final voice of product quality. I am a recognized expert on Pharmaceutical Water Systems (Clean Steam, Water for Injection (WFI), Purified Water, Reverse Osmosis, Deionized Water), Environmental Monitoring, Aseptic Processing, and Bacterial Endotoxins/LAL Testing. I have been the leader on Six Sigma and Quality by Design Projects. I have experience managing staff of between 6 and 20 personnel and have successfully managed several product configurations from early product design requirements to product regulatory approval and launch.I have experience in authoring, reviewing, and approving global regulatory submissions and working with government ministry of health agencies worldwide.I have successfully collaborated with multiple corporate partners including the establishment of corporate quality agreements.I have also worked with a local community college to serve as guest lecturer on microbial testing and bacterial endotoxins/LAL testing.