Adam Pinkert ME Quality Assured AI

Adam Pinkert is a senior Biotech quality consultant and executive with 30+ years of experience in compliance, FDA remediation, quality systems implementation, and regulatory strategy. Adam has a proven track record leading inspection readiness, supplier quality management, biotech/CGT operations, and aseptic manufacturing from Phase I through commercial launch. Adam has held senior leadership roles at Resilience, ADMA Biologics, Roche, and Genentech, where he drove regulatory approvals, developed scalable Quality Management Systems (QMS), and introduced lean processes. His expertise includes regulatory/PAI readiness, quality audits, CMC authoring and submission, quality risk management, contamination control, data integrity, tech transfers, and CDMO/CRO oversight, helping companies achieve inspection success and operational excellence.