Specialist, Quality Assurance GCP

Job description

Purpose of the Job The Clinical Quality Assurance Specialist supports the implementation and maintenance of an effective Clinical Quality Management System (QMS) to ensure ICH-GCP compliance for all sponsor-led clinical development activities. The role provides operational QA support and oversight for clinical trials mainly in Phase II to Phase IV, contributing to inspection readiness, vendor oversight, and continuous improvement of clinical quality processes. Qualifications: Company: Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better...