QA Product Manager (Sterile Products)

Job Title: QA Product Manager (Sterile Products)

Overview

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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.