QA Product Manager (Sterile Products)

Job description

Overview The QA Product Manager (Sterile Products) plays a critical role in ensuring the quality, safety, and regulatory compliance of sterile pharmaceutical products manufactured by third-party CMOs. This position partners cross-functionally with global internal teams and external manufacturers to ensure effective implementation of quality systems build and maintain robust quality systems, support sterility assurance and contamination control strategies, and uphold regulatory expectations. This role is accountable for QA activities across the product lifecycle, including technology transfer, validation, batch disposition, auditing, and post-market quality events for assigned products. Responsibilities: - Lead and coordinate end-to-end technology transfer projects for drug substance and/or drug product between R&D, manufacturing sites, and external partners (CMOs/CDMOs) including review of all technical documentation (gap assessments, comparability protocols, equipment qualification, and validation protocols/reports.) - Oversee and provide guidance on the execution of validation activities related to sterile manufacturing processes, including process validation and sterilization va...