Specialist, Quality Assurance
Core
Ensuring quality compliance for the importation and commercial operation of Cell Therapy Finished Products in Japan.
Role type
Specialist, Quality Assurance (Cell Therapy)
Builds
Commercial Cell Therapy Products for Japan
Domain
Biopharmaceuticals / Cell Therapy / Regulatory Compliance
Deliverable
client delivery
Required skills
cGMP principles, Quality Management Systems (QMS), deviation management, change control, product complaint investigation, regulatory inspection readiness, audit management, import lot disposition
Preferred skills
Japanese regulatory knowledge (PMDA), parenteral/aseptic operations, Microsoft Office, web-based systems
Technologies
QMS systems, web-based digital tools
Responsibilities
Monitor importation of Cell Therapy Finished Products; Maintain and update local QMS/GQP; Approve deviations, change controls, and product complaints; Interface with manufacturing sites to resolve quality events; Support regulatory inspections and self-inspections; Conduct internal or external audits.
Seniority
Specialist, individual contributor
