Associate Director, External Manufacturing Quality, Cell Therapy Global Quality
Core
Provide Quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs) to support the clinical and commercial release of cell therapy drug products in the APAC region.
Role type
Associate Director, External Manufacturing Quality (Cell Therapy)
Builds
Ensures compliance and quality of third-party manufacturing operations for biologics and cell therapy products.
Domain
Biopharmaceuticals / Cell Therapy / GCTP/GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCTP/GMP compliance expertise, aseptic processing background, Japanese and English fluency, Six Sigma methodologies, project management, risk assessment, audit management, batch record review, CAPA management, change control oversight.
Preferred skills
Experience overseeing GCTP/GMP operations in a commercial CMO, continuous improvement, operational excellence.
Technologies
GCTP, GMP, Six Sigma tools, process mapping software, root cause analysis frameworks.
Responsibilities
Provide QA oversight of CMOs for deviations, CAPAs, change controls, and batch record review; conduct annual risk assessments and routine/for-cause audits of CMOs; oversee technology transfer and routine GCTP/GMP operations at CMOs; act as QA impact assessor and approver of CMO-related changes; review and approve protocol/reports for regulatory submissions; develop and approve annual product review reports generated by CMOs; assist in CMO GCTP/GMP audits; provide teaching and coaching for junior team members.
Seniority
Senior, hands-on IC with leadership responsibilities
