QA Product Manager (Sterile Products) - Contractor
$101,920–$122,720 year
On-siteFlorham Park, New Jersey, United States
Job Summary
Review manufacturing and packaging batch records, escalate issues, and perform final disposition of assigned sterile products. Support and coordinate investigations for deviations, OOS/OOT, and product complaints, initiating CAPAs to 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, support documentation needs for change controls and stability protocols, and track audit findings for effective CAPA implementation. Lead large-scale technology transfers and build or negotiate new or existing quality agreements. Collaborate with Supply Chain, Regulatory, and other partners to ensure continued product quality and supply continuity. Work 50% of the time at the Florham Park, NJ corporate office.
Required Qualifications
- Minimum 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
- Ability to work 50% of the time a month at Florham Park, NJ corporate office
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