Manager, Supplier Quality
Core
Ensuring supplier activities comply with policies, standards, and global cGMPs to support commercial and clinical operations for radiopharmaceutical therapies.
Role type
Manager, Supplier Quality
Builds
Approved Vendor Lists, Quality Agreements, material lifecycle management programs, and supplier audit outcomes.
Domain
Biopharmaceuticals / Oncology / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GDP compliance, supplier qualification, material lifecycle management, change management, CAPA handling, supplier audit leadership, regulatory knowledge (US/EU), SAP familiarity
Preferred skills
Quality Risk Management, managing raw material/consumable services suppliers
Technologies
SAP
Responsibilities
Oversee GMP/GDP vendor qualification and management; manage material lifecycle including qualification and change control; lead supplier audits and evaluate observation responses; handle discrepancy reporting and CAPA for non-conforming materials; coordinate cross-functional meetings for vendor management; participate in corporate and health authority inspections.
Seniority
Manager, hands-on leadership