Manager GMP Quality Operations
Core
Expert in GMP quality assurance and AI-enabled operations supporting manufacturing of Cell & Genetic Therapeutics.
Role type
Manager, GMP Quality Operations
Builds
Intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving within GMP environments.
Domain
Biotechnology / Cell & Gene Therapy / GMP Quality Systems
Deliverable
production ML models | dashboards & analysis | infrastructure
Required skills
GMP QA experience, AI solution design, Python, Power BI, Oracle, TrackWise, Veeva, risk-based decision making, project leadership
Preferred skills
Experience leading projects/teams, developing digitization solutions for efficiency
Technologies
Python, Power BI, Oracle, TrackWise, Veeva, Smartsheet
Responsibilities
Support QA of manufacturing operations across development phases; oversee Quality System compliance (CAPA, change control, risk management) with CDMOs; develop and maintain quality metrics dashboards; partner with CDMOs for operational efficiencies; support audit readiness; develop AI solutions for records archiving and lifecycle management; implement AI-supported records reconciliation; lead Cell & Genetic Program quality projects.
Seniority
Manager, hands-on IC with team leadership