External QA Specialist/Manager
Core
Provide quality oversight of Contract Manufacturing Organizations (CMOs) for monoclonal antibody programs, covering selection, qualification, ongoing management, and decommissioning.
Role type
Senior IC QA Specialist/Manager (Supplier Quality)
Builds
Monoclonal antibody drug products (clinical and commercial batches), packaging, labelling, and storage
Domain
Biopharmaceuticals / Biologics / Contract Manufacturing
Required skills
cGMP compliance, supplier qualification, Quality Agreements, risk-based quality oversight, GMP audits, CAPA management, batch record review, regulatory submissions
Preferred skills
IMP supply chain experience, electronic Quality Management Systems (Veeva, SAP)
Technologies
Veeva, SAP
Responsibilities
Qualify CMOs and negotiate Quality Agreements; Act as Person-in-Plant (PIP) for real-time GMP decisions; Lead GMP audits and monitor inspection outcomes; Drive CAPA implementation and root cause analysis; Support regulatory submissions and CMC programs; Monitor supplier quality metrics and performance.
Seniority
Senior, hands-on IC