Senior Auditor Cell Therapy Quality
Core
Senior auditor conducting independent appraisals of quality and compliance systems for AstraZeneca Cell Therapy manufacturing sites, contractors, and suppliers.
Role type
Senior QA Auditor (Cell Therapy)
Builds
Compliance assurance for cell therapy manufacturing and supply chain
Domain
Biopharmaceuticals / Cell Therapy / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP interpretation and application, Cell Therapy product knowledge, risk-based auditing, corrective and preventive action development, regulatory agency liaison, cross-cultural communication
Preferred skills
Experience overseeing auditing, GXP areas (GLP, GCP)
Technologies
cGMP, ISO Standards, IPEC, ICH Q7A
Responsibilities
Conduct domestic and international audits of suppliers and internal departments, interpret audit findings and support corrective actions, liaise with senior management on compliance status, maintain contacts with regulatory agencies, develop audit findings across the Global Quality Audit scope
Seniority
Senior, hands-on IC