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.
