QA Product Manager (Sterile Products)

Job Title: QA Product Manager (Sterile Products)
Location: Florham Park, New Jersey
Type: Direct Hire
Compensation:
Work Model: Hybrid – onsite and remote

Responsibilities

• Lead and coordinate end-to-end technology transfer projects for drug substance and/or drug product between R&D, manufacturing sites, and external partners (CMOs/CDMOs) including review of all technical documentation (gap assessments, comparability protocols, equipment qualification, and validation protocols/reports.)
• Oversee and provide guidance on the execution of validation activities related to sterile manufacturing processes, including process validation and sterilization validation.
• Lead the Quality Assurance activities for sterile pharmaceutical products manufactured by third-party manufacturers including change controls, product quality incidents, deviations, non-conformances, out of specification/out of trend investigations, product complaints and CAPAs.
• Review batch records and perform final disposition.
• Conduct rigorous assessments and audits of potential and existing third-party manufacturers to ensure they meet our quality standards and regulatory requirements.
• Collaborate with Regulatory Affairs teams to support product registrations, submissions, and regulatory inspections related to third-party manufacturing.
• Assist in drafting and negotiating Quality and Technical Agreements, Annual Product Reviews and Stability Protocols.
• Other duties as assigned.

Requirements

• Bachelor's degree in Life Sciences (Biology, Microbiology, Pharmaceutical Sciences, Chemistry, or a related field). Advanced degree is desirable.
• Minimum of five (5) years of experience in pharmaceutical Quality Assurance, with a focus on sterile products and third-party manufacturing including 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 (e.g., reactors, autoclaves, lyophilizers, filling lines, HVAC, utilities).
• Strong understanding of sterile manufacturing processes, sterility assurance practices, equipment lifecycle management, and validation requirements.
• Experience working with third-party manufacturers (CMOs/CDMOs) and managing quality assurance activities related to sterile products including demonstrated ability to perform audits and quality assurance activities for sterile products.
• Demonstrated project management skills, including the ability to prioritize tasks, meet deadlines, and manage multiple, concurrent projects involving third-party manufacturers.
• Experience conducting internal and external audits in a cGMP-regulated environment, including third-party manufacturers (CMOs/CDMOs).
• Experience with quality management systems (e.g., Veeva or similar).
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Ability to lead end-to-end technology transfer and quality activities with full ownership and accountability.
• Applies risk-based decision-making in complex, high-stakes manufacturing environments.
• Strong technical expertise in sterile manufacturing processes and validation.
• Demonstrated ability to lead thorough investigations and implement effective CAPAs.
• Effectively influences cross-functional stakeholders and drives alignment without direct authority.
• Experience overseeing and holding external manufacturing partners (CMOs/CDMOs) accountable.
• Strong understanding of global GMP and regulatory requirements (FDA, EMA, ICH).
• Ability to manage multiple priorities while maintaining quality and compliance standards.
• Communicates complex technical information clearly to both technical and non-technical audiences.

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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Ref: #568-Clinical