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 comprehensive quality performance improvement.
Prior to 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 comprehensive Quality System improvements, and drove extensive 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 world wide 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.
Previously, John held various Quality Assurance, Operations, Technical Support and Project Management roles of increasing responsibility with Abbott, Genentech and Roche. He received his Bachelor of Science degree in Chemical Engineering from Purdue University and his Masters in Business Administration from the University of Chicago.
Expertise: Quality System design and implementation, Quality remediation at the site and corporate level, Validation, FDA, EMA, ICH, PICs