Mr. Gabriele Gori has been in the sterile Pharmaceutical / Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, but not limited to, Bausch & Lomb, Novartis and GlaxoSmithKline.
His experience covers R&D, Engineering, Quality Control, Quality Assurance and GXP Compliance: since September 2015 he has been in role as Vice President, Global Head of Audit and Risk Management at GlaxoSmithKline Vaccines.
Sterility Assurance expert, from 2012 to 2015 he chaired the Novartis Sterility Assurance Expert Network (SAEN) – a multidivisional and multifunctional team of experts aimed at providing direction to the Novartis Group as regards Sterility Assurance matters. 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 on Aseptic Processing and Quality Systems related matters. Most recently, he has been the co-chair of the Parenteral Drug Association (PDA) task force in charge of developing a “Points to Consider“ document for modern aseptic manufacturing (the part 1 of the document has been published by PDA in March 2015, the part 2 in April 2016) and co-chair of the task force in charge to develop the PDA comments to the revised draft of the European GMP – Annex 1 – “Manufacture of Sterile Medicinal Products” (2018).
A member elected of the PDA Board of Directors from 2010 through 2015, he is now part of the Science Advisory Board of the association. In 2016-2017 he has been the representative of Vaccines Europe, a trade association of the European manufacturers of Vaccines, in the Technical Development Expert Group (TDEG) of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Mr Gabriele Gori holds a bachelor in Chemistry (University of Florence – Italy) and a master in Quality Management (University of Pisa – Italy).