Senior Specialist Global QMS
Core
Implement and maintain a global Quality Management System (QMS) for cell therapy manufacturing, ensuring compliance with GxP and regulatory standards across multiple sites.
Role type
Senior Specialist, Global QMS (Quality Management System)
Builds
Global quality program supporting commercial readiness and clinical programs for cell therapy products
Domain
Biotechnology / Cell Therapy / GxP-regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulations knowledge, internal audit program leadership, supplier qualification and management, inspection readiness management, QMS KPI trending, validation oversight, electronic QMS system administration
Preferred skills
Multi-site global quality organization experience, advanced degree in scientific or engineering discipline
Technologies
MasterControl, ERP systems, Trackwise
Responsibilities
Plan and execute internal audits across all sites and functions; Develop audit agendas, conduct interviews, and generate reports; Support the global Quality Management Review (QMR) process; Manage supplier qualification and risk assessments; Drive global inspection readiness for FDA, EMA, and other health authorities; Establish and monitor global QMS KPIs; Partner with IT to implement QMS system enhancements; Review and approve validation documentation for global enterprise systems; Collaborate on continuous improvement initiatives
Seniority
Senior, hands-on IC