QA Product Manager (Sterile Products)

QA Product Manager (Sterile Products)Location: Florham Park, New Jersey Type: Contract Compensation: $45-$59 per hour dependent on years of experience and education. Contractor Work Model: Hybrid onsite and remote Hours: 40.0 hours per weekResponsibilitiesReview manufacturing and packaging batch records; escalate issues and perform final disposition of assigned products.Support and coordinate investigations (deviations, OOS/OOT, product complaints), initiate CAPAs, and ensure timely closure.Maintain ongoing communication with contract manufacturers to resolve quality issues, monitor compliance, and ensure product release readiness.Provide QA input during regulatory inspections and support documentation needs (change controls, stability protocols, technical agreements).Assist in ensuring that audit findings are tracked and CAPAs are effectively implemented.Collaborate with Supply Chain, Regulatory, and other partners to ensure continued product quality and supply continuity.Lead large-scale technology transfers.Build or negotiate new or existing quality agreements.Provide support for Developmental Products as needed.RequirementsMinimum 4 years of experience of QA experience in sterile drug product manufacturing/oversight.Strong background in batch record review, CAPA management, and sterility assurance.Direct experience with third-party (CMO) oversight.Able to operate independently with minimal supervision.Comfortable working cross-functionally and representing QA in external partner interactions.Experience with quality management software and tools such as Veeva including demonstrated computer experience with MS Word, Excel, and Outlook.Strong knowledge of regulatory requirements and guidelines, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards.