QA Product Manager – Sterile Products

Shionogi Inc. (U.S.)

QA Product Manager ensuring quality, safety, and regulatory compliance of sterile pharmaceutical products at Shionogi Inc. Leading technology transfer and Quality Assurance activities across product lifecycle.

Posted 5/1/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $150,000 per yearWebsite

About the role

Key responsibilities & impact

Lead and coordinate end-to-end technology transfer projects for drug substance and/or drug product
Oversee and provide guidance on the execution of validation activities related to sterile manufacturing processes
Lead the Quality Assurance activities for sterile pharmaceutical products manufactured by third-party manufacturers
Review batch records and perform final disposition
Conduct rigorous assessments and audits of potential and existing third-party manufacturers
Collaborate with Regulatory Affairs teams to support product registrations, submissions, and regulatory inspections

Requirements

What you’ll need

Bachelor's degree in Life Sciences (Biology, Microbiology, Pharmaceutical Sciences, Chemistry, or a related field)
Minimum of five (5) years of experience in pharmaceutical Quality Assurance with a focus on sterile products and third-party manufacturing
Strong understanding of sterile manufacturing processes, sterility assurance practices, equipment lifecycle management, and validation requirements
Experience leading or supporting technology transfer activities across a range of equipment types
Experience conducting internal and external audits in a cGMP-regulated environment including third-party manufacturers
Proficiency in Microsoft Office (Word, Excel, Outlook)

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

technology transfervalidation activitiessterile manufacturing processesQuality Assurancebatch record reviewauditscGMPsterility assurance practicesequipment lifecycle managementregulatory submissions

Soft Skills

leadershipcollaborationguidancecommunication