Site Quality Manager
Core
Lead quality operations and provide quality oversight for manufacturing operations, laboratory activities, and quality systems in a GMP environment.
Role type
Site Quality Assurance Manager
Builds
Manufacturing operations, laboratory activities, and quality systems
Domain
Pharmaceutical services and technology, medtech, life science tools and diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, regulatory inspection management, CAPA implementation, risk management, document control, change control, validation, team leadership, project management
Preferred skills
Six Sigma, ASQ certification, advanced degree in Chemistry/Biology/Engineering/Pharmacy
Technologies
Quality systems software
Responsibilities
Lead quality operations and provide quality oversight for manufacturing operations, laboratory activities, and quality systems; Host and manage regulatory inspections and customer audits; Implement and maintain robust quality systems, including document control, change control, deviations, CAPA, and validation; Drive continuous improvement initiatives and apply risk management tools
Seniority
Manager, leadership role