John McShane is a Managing Partner at Validant, based in San Francisco. John brings extensive experience in Quality Systems and remediation with a track record of overall quality performance improvement. Before joining Validant, John most recently served as a Director in External Biologics Quality Assurance at Roche for four years. In this capacity, John led the Quality efforts on outsourcing of major biologics to two contract manufacturers in Asia. Working with Samsung, he led overall Quality System improvements, and drove great inspection readiness initiatives, resulting in Samsung receiving zero observations in their first FDA PAI.
Additionally, John held a previous role as Head of Biologics Quality System for Roche. In this position and earlier positions at Genentech and Abbott, John helped design the corporate Quality System in compliance with worldwide Health Authority expectations across all major global markets and diverse product portfolios. As part of these positions, he led critical Quality efforts such as interim Quality Site Head interfacing with Health Authorities and executing a Quality Improvement Plan, warning letter remediation, Quality integration of new sites and corporate Quality improvement in tank management.
Since 2008, John has been an active PDA Member and co-authored "PDA's Technical Report 60 Process Validation: A Lifecycle Approach".
John holds a Master’s Degree in Business Administration from the University of Chicago and a Bachelor’s Degree in Chemical Engineering from Purdue University.