Stephen Tyrpak Associate VP of Operations; US & Canada, and Associate Partner with PQE Group

Stephen is a healthcare executive and commercialization expert with over 15 years’ experience working with pharmaceutical, medical device, and combination products, supporting companies in the US and around the globe in various areas requiring his expertise.  Stephen has spent years corroborating with an array of different specialties including, but not limited to, creating and optimizing global cGMP quality systems specifically focused on Aseptic Manufacturing and creating robust Manual Visual Inspection (MVI) and CAPA programs. He acts as US agent for global Pharmaceutical and Medical Device companies and provides support in the preparation and possible remediation required as a result of Regulatory Inspections. He has assisted startup companies from around the globe in raising over $120 million in commercial seed funding and over $12 million in US state and federal grants often used to bring novel therapies to market. He is recognized as a commercialization expert, senior Business Advisor, and is an invited speaker and panel expert in the areas of regulatory affairs, MVI, GXP compliance and startup business strategy. He is a peer reviewed published author, keynote speaker, a member of the Medical Device Manufacturers Association (FDA and Compliance Working groups) and sits as the Chair of D'Youville Universities' Founders Board for their School of Medicine, on The University at Buffalo's CBLS & CAT Industrial Advisory Board & on the Board of Directors for the Mental Health Advocates of Western New York (WNY). He was one of WNY’s 30 under 30.