QA Product Manager, Sterile
Shionogi Inc. (U.S.)
contract
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $65 - $85 per hour
Job Level
Mid-LevelSenior
About the role
- Provide temporary QA support to maintain quality and compliance oversight of sterile pharmaceutical products manufactured by third-party partners.
- Review 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 Shionogi Developmental Products as needed
Requirements
- 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.