QA Product Manager (Sterile Products) - Contractor

Shionogi Inc. • Florham Park, NJ

1d • Hybrid

About The Position

The contractor will provide temporary QA support to maintain quality and compliance oversight of sterile pharmaceutical products manufactured by third-party partners. The focus will be on batch release, issue resolution, and regulatory compliance for the duration of the assignment. This role will ensure continuity in QA oversight without disruption to supply or compliance commitments.

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.

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 Shionogi Developmental Products as needed.

Benefits

• The hourly rate for this position is $65 - $85.
• Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training.
• The range does not include the comprehensive benefits, bonus, applicable allowances, or any additional compensation that may be associated with this role.

What This Job Offers

• Career Level: Mid Level
• Education Level: No Education Listed