QA Product Manager (Sterile Products)

About the role

A fantastic opportunity to join a leading biotechnology company. This position offers a competitive compensation range of $45-$59 per hour, dependent on experience and education.

Responsibilities

• 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 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.