MogiSystem One
QA Product Manager (Sterile Products)
Full-time
About the job
Job Title: QA Product Manager (Sterile Products) Location: Florham Park, New Jersey Type: Direct Hire Compensation: Work Model: Hybrid – onsite and remote 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 validation. • Lead the Quality Assurance...