Michele Simone Bracco Suisse

Michele Simone

Michele Simone Bracco Suisse

Michele Simone is a Biologist and Clinical Pathologist by education. "Qualified Person" according to Directive 2001/83/EC.

He is currently acting as Director of Corporate Quality Risk Management & Continual Improvement for the Bracco Group, an international group active in the healthcare sector, and a global leader in diagnostic imaging.

Michele has + 28 years’ experience in the pharma/biopharma industry, and he holds different sites and corporate roles in different Quality organization, including, but not limited to Serono, Janssen Cilag, J&J, Novartis V&D and Merck.

Michele is an active member of PDA since 2002. He is part of PDA Chapter Italy - Board of Directors since 2014. He has served as Secretary in the last mandate. He is currently a member of PDA RAQAB and he is the Chair of the PDA IG “Quality System”. He has been part of the PDA Task Force “Remote Audits and Inspections” and he contributed to issue the PDA Point of Consider – Remote Audits and to review the PDA Point of Consider – Remote Inspections.

Michele often serves as chair and lecturer at major conferences on topics including quality management, supplier quality management, process continual improvement, contamination control strategy, quality risk and knowledge management.