Senior Quality Assurance Specialist, Material Supplier
Core
Lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality, compliance, and supply.
Role type
Senior Quality Assurance Specialist (Material Supplier)
Builds
Global coordination for supplier change notifications and quality programs
Domain
Pharmaceutical/Regulatory Quality Assurance
Required skills
Supplier change notification management, GMP compliance, risk assessment, CAPA execution, regulatory inspection support, project management, document control
Preferred skills
Partnering with GMP material suppliers, previous quality experience in GMP environment
Responsibilities
Reviews and coordinates Supplier Change Notifications across global suppliers, Supports resolution of internal and external deviations, Maintains and updates controlled documents related to supplier change notification, Supports execute Corrective/Preventative Actions (CAPAs), Gathers and evaluates information for regulatory inspections and audits, Performs continuous improvement of the Material & Supplier Quality program, Manages and tracks projects to ensure milestones are achieved
Seniority
Senior, hands-on IC