Wylie McVay

Wylie McVay is a Regulatory Quality Specialist SME at Conceptual MindWorks, Inc. since October 2016, providing consulting on cGMPs, quality systems, and regulatory strategy to Federal project teams, particularly in IVD, Devices, antibiotics, and small molecule products. Wylie also serves as an Assistant Adjunct Professor at Temple University School of Pharmacy, instructing on Unit Operations related to pharmaceutical dosage form design and quality. Previous roles include Associate Director Regulatory CMC at Windtree Therapeutics, Inc., Senior Specialist Regulatory CMC at Merck Consumer Health Care, and Associate Director Regulatory CMC at Valeant Pharmaceuticals International, focusing on CMC lifecycle strategies and post-approval filings. Wylie has extensive experience at Pfizer as Senior Manager Global CMC and has contributed to the validation technology field as an editorial review board member. Academic achievements include an MS in Quality Assurance/Regulatory Affairs from Temple University, an MBA from the University of Oklahoma, and a BA in Chemistry from the University of Richmond.