Lead Specialist, QA Operations Lot Disposition

SUMMARY

The Lead Specialist, QA Operations Lot Disposition supports timely and compliant release of externally manufactured drug product, viral vector materials, and vendor‑supplied starting materials used in gene therapy programs. This role serves as a subject‑matter resource within the team, guiding junior reviewers, coordinating documentation flow, and helping ensure right‑first‑time disposition packages. The Lead Specialist partners closely with External Manufacturing, Quality, Supply Chain, and Technical Operations to keep batch documentation on track and audit‑ready.

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

RESPONSIBILITIES

• Coordinate completion and review of lot disposition packages, ensuring timely batch record, CoA/CoC, deviation, and supporting documentation readiness.
• Perform detailed quality review of batch records and supporting documents for external DP and viral vector manufacturing.
• Support review and release of vendor‑provided starting materials and raw materials used in gene therapy processes.
• Serve as a point of contact for documentation questions from internal teams and external manufacturing partners.
• Track lot status and proactively identify risks, gaps, or delays in documentation availability.
• Assist with investigation summaries, data reconciliation, and communication of document issues to cross‑functional teams.
• Support audit and inspection readiness by ensuring disposition files remain complete, accurate, and organized.
• Provide documentation and information during internal/external audits and help prepare responses.
• Drive and support process improvements and operational excellence initiatives related to the documentation and disposition workflow.
• Mentor or guide junior specialists on documentation expectations, quality standards, and system navigation.
• 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 discipline preferred (Biology, Biotechnology, Chemistry, Engineering).
• 4+ years of experience in a regulated biopharmaceutical, gene therapy, biologics, or medical device environment.
• Hands‑on experience with GMP documentation, batch record review, or lot disposition activities.
• Familiarity with external manufacturing environments (CMOs/CDMOs).
• Proficiency with electronic systems such as eQMS, document management platforms, or LIMS.
• Strong organizational skills with excellent attention to detail.
• Ability to interpret procedures, quality standards, and regulatory expectations.
• Effective communication skills for cross‑functional and external partner interaction.

 PREFERRED QULIFICATIONS:

• Experience with viral vector or biologics manufacturing.
• Exposure to raw material qualification or material release processes.
• Understanding of FDA regulations for advanced therapies.