Florham Park, New Jersey30+ days ago
This role involves collaborating with cross-functional teams (regional and global), including external manufacturers, Supply Chain, Regulatory Affairs, and Pharmaceutical Sciences, to establish robust quality systems, implement sterility assurance practices including effective contamination control strategies, and maintain adherence to regulatory guidelines. Resolve quality issues, including initiating internal and coordinating external product-related investigations, deviations, OOS/OOT investigations, CAPAs, change controls, and quality complaints related to the manufacturing, packaging, and testing of assigned products.