Senior Manager, External Manufacturing Quality, Cell Therapy Global Quality
Core
Provide quality oversight of technology transfer and routine GCTP/GMP operations at CMOs for cell therapy intermediate product manufacturing.
Role type
Senior Manager, External Manufacturing Quality
Builds
Cell therapy intermediate products via CMOs
Domain
Biopharmaceuticals / Cell Therapy / GMP
Deliverable
client delivery
Required skills
GCTP/GMP compliance expertise, Japan regulatory knowledge, aseptic processing background, Japanese language proficiency, English language proficiency, batch record review, deviation investigation review, CAPA review, change control assessment, quality risk assessment, audit collaboration
Preferred skills
Experience overseeing GCTP/GMP operations
Technologies
None stated
Responsibilities
Provide quality oversight of technology transfer and routine GCTP/GMP operations at CMOs; Partner with CMO Quality to ensure compliance with regulatory submissions and agreements; Provide quality compliance guidance and oversee readiness for pre-license inspection; Collaborate on continuous improvement of CMO oversight program; Review and approve batch records and product disposition; Review and approve CMO deviation investigations, CAPA, and controlled documents; Act as QA impact assessor for CMO changes; Review protocol/reports for regulatory submissions; Review COI risk assessments and process maps; Develop and approve annual product review reports; Collaborate on implementation of corrective actions from audits; Assist in CMO GCTP/GMP audits; Support management review and metric trending; Develop departmental goals.
Seniority
Senior Manager