Shionogi Inc.
Florham Park, NJ, USA
Overview The QA Product Manager (Sterile Products) is responsible for ensuring the quality and compliance of sterile pharmaceutical products (active pharmaceutical ingredients and/or drug products) manufactured by third-party contractors/suppliers (CMOs). 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. The QA Product Manager will lead quality assurance efforts, review and disposition batches, conduct audits, and drive continuous improvement initiatives to ensure the safety and sterility of our products. Responsibilities The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed...