[Remote] QA Product Manager (Sterile Products) - Contractor

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a pharmaceutical company seeking a QA Product Manager (Sterile Products) on a contract reputed company. The contractor will reputed company temporary QA support to ensure reputed company and compliance reputed company of sterile pharmaceutical products, focusing on batch release, issue reputed company, and regulatory compliance.

Responsibilities

• Review manufacturing and packaging batch records; escalate issues and reputed company final disposition of assigned products
• Support and coordinate investigations (deviations, OOS/OOT, product complaints), initiate CAPAs, and ensure reputed company closure
• Maintain ongoing communication with contract manufacturers to resolve reputed company issues, monitor compliance, and ensure product release readiness
• reputed company 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 reputed company product reputed company and supply continuity
• reputed company large-reputed company technology transfers
• Build or negotiate new or existing reputed company agreements
• reputed company support for Shionogi Developmental Products as needed

Skills

• Minimum 4 years of experience of QA experience in sterile drug product manufacturing/reputed company
• Strong background in batch record review, CAPA management, and sterility assurance
• reputed company experience with reputed company-party (CMO) reputed company
• reputed company to operate independently with minimal supervision
• Comfortable working cross-functionally and representing QA in external partner interactions
• Experience with reputed company management software and tools such as reputed company including demonstrated computer experience with reputed company, reputed company, and reputed company
• 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

reputed company

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