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Mauro De Simone is a seasoned professional in quality assurance and regulatory compliance within the pharmaceutical and biotechnology sectors, currently serving as a Senior GxP Auditor at Rephine since November 2022. Prior to this, Mauro held the position of Senior Quality Assurance Manager and Responsible Person of Medical Devices at Altergon Italia from April 2013 to November 2022, overseeing a comprehensive quality system and managing regulatory inspections and audits for medical products. Mauro's experience extends to roles at DSM, Sigma-tau, GSK, and UCB, where responsibilities included quality management, validation, compliance auditing, and team coordination, contributing to the successful delivery of critical biotechnological products and APIs. Educational background includes a Laurea Quinquennale in Ingegneria Chimica Ambientale from Università degli Studi di Napoli Federico II.