Gabriele Gori Consultant

Gabriele Gori has been in the sterile Pharmaceutical/Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, Bausch & Lomb, Chiron, Novartis, GlaxoSmithKline, Thermo Fisher Scientific, Zambon and Biogen. His experience covers R&D, Engineering, Validation, Quality Control, Quality Assurance, GXP Compliance and Auditing, Quality Operations and includes senior roles e.g. Global Head of Quality for Zambon and Biogen, and the leading of teams of more than 500 associates located in multiple countries across the globe. Currently Gabriele is providing support to the Pharma and Medical Device industry as a consultant. Sterility Assurance and GMP Compliance expert, Gabriele is currently the Chair of the Science Advisory Board (SAB) of the Parenteral Drug Association (PDA): invited speaker in international conferences and workshops on topics dealing with Aseptic Processing, Quality Systems and GMP Compliance, he also provided training to inspectors of European National Health Authorities. He has been further supporting the Industry concerning the review and commenting of the revised EU GMP Annex 1 by co-chairing a dedicated PDA Subject Matter Expert team. Gabriele holds a bachelor in Chemistry (University of Florence – Italy) and a master in Quality Management (University of Pisa/Consorzio Qualital – Italy).