Associate Director, External Quality
Core
End-to-end quality oversight of external manufacturing partners (CDMOs), suppliers, and testing laboratories for commercial and late-stage clinical radio conjugate products.
Role type
Senior IC Associate Director, External Quality
Builds
Reliable, compliant supply of radio conjugates for clinical trials and commercial launch
Domain
Oncology / Radiopharmaceuticals / Biotechnology
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/cGDP/cGLP compliance, external partner quality governance, risk management (FMEA, ICH Q9), deviation/CAPA management, validation/qualification, regulatory inspection readiness, cross-functional leadership, data integrity
Preferred skills
Radio conjugate experience, multi-regional CDMO oversight, Quality Agreement negotiation, sterile manufacturing (Annex 1), serialization/traceability, statistical sampling (SPC)
Technologies
Electronic QMS, electronic batch records, risk assessment tools
Responsibilities
Establish quality governance and performance metrics for external partners; Ensure partner adherence to cGMP/cGDP/cGLP and regional regulations; Lead risk assessments and drive proactive detection/prevention strategies; Oversee quality investigations and approve CAPAs; Ensure partners are inspection ready and support health authority audits; Define and monitor supplier benchmarks; Partner with Technical Operations, Manufacturing, and Supply Chain for reliable supply
Seniority
Senior, hands-on IC with matrix leadership
