Provide GMP quality oversight and technical support to internal manufacturing operations and contract manufacturers (CMOs), ensuring compliance with Quality Agreements and regulatory requirements
Support change control activities, including impact assessments, implementation, review, approval, and closure in accordance with established procedures
Manage and approve deviations, OOS/OOT investigations, and root cause analyses, ensuring appropriate product impact assessments and effective CAPA implementation
Conduct comprehensive GMP document review, including Master and Executed Batch Records, validation protocols, and summary reports to support batch disposition and on-time release
Monitor and maintain Quality Metrics, proactively identifying risks and driving mitigation strategies to ensure compliance and operational performance
Collaborate cross-functionally to support continuous improvement initiatives, strengthen quality systems, and enhance overall GMP compliance

Bachelor’s degree in Life Sciences, Information Systems, Quality, Engineering, or a related discipline
3+ years of experience working in GxP-regulated environments with strong knowledge of applicable regulations (e.g., 21 CFR Part 11, Annex 11, data integrity principles)
Strong working knowledge of cGMP requirements governing drug substance and drug product manufacturing (oral solid dosage forms preferred)
Proven experience leading deviations, event investigations, Root Cause Analysis (RCA), and CAPA in a regulated pharmaceutical environment
Demonstrated ability to support multiple cross-functional projects in a fast-paced setting, ensuring quality, accuracy, and on-time deliverables
Effective communicator with the ability to evaluate quality issues, apply sound technical judgment, and collaborate across departments to resolve compliance matters
Ability to be on-site, part-time in South Boston, MA (Seaport area). 3 days per week on-site at a minimum.

GMP Quality Specialist

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