Overview

The QA Product Manager (Sterile Products) plays a critical role in ensuring the quality, safety, and regulatory compliance of sterile pharmaceutical products manufactured by third-party CMOs. This position partners cross-functionally with global internal teams and external manufacturers to ensure effective implementation of quality systems build andmaintainrobust quality systems, support sterility assurance and contamination control strategies, and uphold regulatory expectations. This role is accountable for QA activities across the product lifecycle, including technology transfer, validation, batch disposition, auditing, and post-market quality events for assigned products.

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.
Assists in drafting and negotiating Quality and Technical Agreements, Annual Product Reviews and Stability Protocols.
Other duties as assigned.

Minimum Job Requirements

Qualifications

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).

Competencies

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

Other Requirements

This is an individual contributor role and has no/some decision-making authority.
Ability and willingness to travel approximately 40% of the year both domestically (25%) and internationally (15%).
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Additional Information

The base salary range for this full-time position is $120,000 - $150,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

Shionogi Inc

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QA Product Manager (Sterile Products)