Associate Director, External Manufacturing Quality, Cell Therapy Global Quality
Core
Provide Quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs) for Cell Therapy drug products in the APAC region.
Role type
Senior IC Associate Director, External Manufacturing Quality (Cell Therapy)
Builds
Cell therapy intermediate products and final drug products for clinical and commercial release
Domain
Biopharmaceuticals, Cell Therapy, GCTP/GMP
Required skills
GCTP/GMP compliance, Aseptic processing, Japanese and English (fluent), Risk assessment, Audit management, Change control, CAPA management, Batch record review, Lot disposition, Six Sigma methodologies, Project management
Preferred skills
CMO oversight experience, Operational excellence, Continuous improvement
Technologies
GCTP, GMP, Six Sigma
Responsibilities
Provide QA oversight of CMOs for deviations, CAPAs, change controls, and batch record review; Ensure CMO compliance via annual risk assessments and audits; Proactively identify risks and improvement opportunities; Partner with CMO Quality to ensure adherence to regulatory submissions and agreements; Oversee readiness for pre-license inspections; Collaborate on lifecycle management of CMO oversight programs; Review and approve CMO deviation investigations, CAPAs, and controlled documents; Act as QA impact assessor for CMO-related changes; Support management review and trend quality metrics; Provide coaching to junior team members.
Seniority
Senior, hands-on IC with leadership responsibilities