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.

 

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‑ready.

- 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.