Back

Stéphane GUMY

General Manager

Biography: Stéphane Gumy is an expert in quality, regulatory affairs, and operations within the (bio)-pharmaceutical and medical device industries, bringing 30 years of experience in biopharmaceutical manufacturing and 15 years in the medical device sector. Trained as a Chemist (EHS), he has held managerial positions across Regulatory Affairs, Quality Assurance, Quality Control, and Production, working within both international corporations and small to mediumsized enterprises. Throughout his career, he has served as a Contracted Qualified Person (QP), providing strategic leadership and oversight for compliance, product quality, and operational performance across diverse environments. Since 2007, he has been an independent consultant and the founder of PMS Process Management System LLC, a consulting company based in Fribourg, Switzerland, supporting clients with expert guidance in quality systems, regulatory compliance, and operational excellence. In his role as a Contracted QP for ATMPs, he offers handson expertise to strengthen pharmaceutical processes, troubleshoot complex quality challenges, and ensure full regulatory alignment. He supports companies throughout the entire product lifecycle (from preclinical development to commercialization) conducting audits, providing quality and regulatory advice, reviewing documentation, and guiding organizations through critical decisionmaking to meet stringent compliance requirements.

Educational CHALLENGES IN CRYOPRESERVATION FOR CELL & GENE THERAPIES

05/27/2026 | 10:00 - 10:35 | TPD Room

Panel Discussion CHALLENGES IN CRYOPRESERVATION FOR CELL & GENE THERAPIES

05/27/2026 | 11:15 - 11:30 | TPD Room