Gustavo Henrique Spaziano

Professional with over 19 years of experience in pharmaceutical quality management and project management, with extensive technical knowledge in manufacturing, validation processes, and quality audit management within multinational companies.Throughout my career, I have held roles that provided me with a comprehensive view of operations in international environments. I have managed teams as a Quality Supervisor, led projects such as pharmaceutical technology transfer and plant startups, and acted as a Global Quality Lead Auditor. In this role, I conducted audits across Contract Manufacturers, CROs, company manufacturing sites, marketing affiliates, warehouses, suppliers, and service providers (Laboratories, RD, etc.) against relevant GxP and industry regulations, including Eudralex, FDA, FAMI-QS, WHO, MAPA, ICA, SAG, ISO, HACCP, ICH, VICH, OECD, and companyspecific requirements.I have performed audits in more than 20 countries, covering regions like Latin America (Brazil, Mexico, Argentina, Colombia, etc.), NorthAmerica (US and Canada), and Europe (Germany, Italy, France, Spain, etc.), gaining a global perspective and results-oriented approach. Additionally, I have been a technical co-responsible for MAPA and took part in leadership during the implementation of ISO 9001 standards.As QA Latam Leader, I was responsible for leading quality management across Latin America (Mexico, Panama, Colombia,Brazil, Argentina, Chile, and associated countries), maneging marketing affiliate quality systems and ensuring the supply of high quality products. (Source: Lattes Curriculum)