Luciana Mansolelli, PharmD, has over 26 years of experience in the pharmaceutical industry. She holds an MBA in strategy. Luciana joined Novartis is 2007 and has worked in different roles of increasing responsibility in technical operations and quality. She has extensive experience in auditing and inspection management, having worked in the corporate audit and compliance function for eight years. She worked in Novartis’ cell and gene technical development and manufacturing plant in the US as Manufacturing Sciences and Technology head. Currently she serves as Large Molecule and Advanced Therapies Regulatory Compliance head for Janssen Pharmaceutical Companies of J&J. Luciana has been an ISPE member since 2015.