Senior Quality Systems Specialist
eGenesisXenotransplantation company
Cambridge, United StatesSenior
Lux Capital
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Operations & Strategy
About the role
TL;DR
Implement and manage Quality Systems for GMP Manufacturing and Testing.
- •eGenesis is seeking a Senior Quality Systems Specialist to support the QA team in implementing and managing Quality Systems for GMP Manufacturing and Testing.
- •This role involves cross-functional interaction and is crucial for ensuring compliance across all eGenesis locations.
- •Key Responsibilities Develop, implement, and maintain processes for QA oversight of clinical study material manufacturing.
- •Manage deviations and CAPAs, ensuring timely closure across all sites.
- •Administer Electronic Laboratory Notebooks for batch records and test methods.
- •Oversee documentation management, including archival and change controls.
- •Manage organizational training programs, including matrices and metrics.
- •Requirements Bachelor's degree in a scientific or operational discipline with 5+ years of quality system management experience, or 7+ years of relevant GLP/GMP quality systems experience.
- •Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures.
- •Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP).
- •Strong analytical, problem-solving, and communication skills.
Domain expertise
biotech