Managing Partner John McShane focuses on biopharmaceuticals. He’s based out of our San Francisco headquarters.
Prior to joining Validant, John served as Director in External Biologics Quality Assurance at Roche, where he notably oversaw the technical transfer of a major biotechnology drug substance to Samsung Biologics in Korea, achieving zero observations during their first FDA PAI. With an enviable track record of architecting comprehensive Quality Systems improvements, driving extensive inspection readiness initiatives, and leading large Ph.D-inclusive staffs, John is a unique asset for Validant's clients.
In addition to his time at Roche and 25+ year tenure at Abbott Laboratories, where he led Corporate Quality Programs, John oversaw Corporate Validation and Quality Risk Management for Genentech. He holds a Master’s Degree in Business Administration from University of Chicago and a Bachelor’s Degree in Chemical Engineering from Purdue University. He’s the co-author of “PDA Technical Report 60: Process Validation” and a member of the International Society of Pharmaceutical Engineers and the Parenteral Drug Association.