Manager, QA Operations Disposition

SUMMARY

The Manager, QA Operations Disposition role supports the release of externally manufactured drug products, viral vector materials, and qualified starting materials used in Genetix Cell & Gene therapy (CGT) programs. This role ensures that incoming documentation packages meet internal quality standards and regulatory expectations while enabling timely product availability. The position plays a key role in maintaining compliant supply flow from external manufacturing partners and material vendors. The individual works cross‑functionally with Quality, External Manufacturing, Supply Chain, and Technical Operations to ensure right‑first‑time disposition activities.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Perform quality review of executed batch records, CoAs, CoCs, deviation summaries, and supporting documentation for external drug product and viral vector manufacturing, ensuring compliance with cGMP and internal procedures.
• Support timely disposition of vendor‑provided starting materials by reviewing supplier documentation, qualification records, and material release files.
• Partner with External Manufacturing, MSAT, and Supply Chain to track batch status and document readiness, escalating issues to ensure on‑time release.
• Document observations, data gaps, and quality concerns; coordinate with internal teams and external partners to drive resolution.
• Maintain accurate records within electronic quality systems, including document management, deviations, and change control workflows.
• Support continuous improvement initiatives aimed at strengthening lot disposition processes and external collaboration models.
• Assist with preparation for audits and inspections by ensuring disposition documentation is complete, accurate, and inspection‑
• Support internal and external audits by preparing, organizing, and providing lot disposition documentation, including batch records, CoAs/CoCs, deviation summaries, and supporting evidence.
• Assist in developing and implementing corrective and preventive actions (CAPAs) arising from audit observations related to lot disposition or external manufacturing documentation.
• Support User Acceptance Testing and implementation of a digitalized CGT lot disposition process
• Proactively identify and drive operational excellence opportunities within the lot disposition process to enhance efficiency, reduce cycle time, and strengthen compliance.

QUALIFICATIONS

• Bachelor’s degree in a STEM field (Biology, Biotechnology, Chemistry, Engineering, or related discipline).
• 7+ years of experience in a regulated biopharmaceutical, biologics, or gene therapy manufacturing environment, with direct exposure to cGMP quality systems.
• Demonstrated experience performing lot disposition, batch record review, or quality review activities for externally manufactured materials or products.
• Experience collaborating with CMOs/CDMOs, including navigating external partner quality systems, document flows, and communication pathways.
• Strong understanding of GMP documentation standards, including batch records, CoAs/CoCs, deviation investigations, and technical reports.
• Proficiency with electronic systems such as eQMS, document management systems, LIMS, and/or batch record management platforms.
• Ability to interpret and apply regulatory expectations from FDA, EMA, and ICH relevant to biologics, aseptic operations, and advanced therapy medicinal products (ATMPs).
• Excellent organizational, analytical, and communication skills, with ability to independently prioritize across multiple concurrent batches and partner sites.
• Demonstrated ability to drive completion of documentation, investigations, and audits in collaboration with cross‑functional and external teams.