This role serves as a Quality leadership position within Thermo Fisher Scientific to ensure excellence in Quality Assurance operations
Job Summary
This role serves as a Quality leadership position within Thermo Fisher Scientific to ensure excellence in Quality Assurance operations.
The successful candidate will lead the team in maintaining product quality and regulatory compliance while supporting the manager as needed.
Key responsibilities include leading customer audits, managing deviation investigations, and liaising with Japanese regulatory authorities for business license renewals.
Matching Summary
This role serves as a Quality leadership position within Thermo Fisher Scientific to ensure excellence in Quality Assurance operations.
Skills & Requirements
Must-have
Licensed Pharmacist in Japan
GMP and QMS knowledge
Batch record review expertise
Deviation management skills
Customer audit coordination
Regulatory liaison with authorities
Nice-to-have
2+ years QA or manufacturing experience
FDA, EMA, ICH guideline knowledge
Risk-based quality approach
English meeting communication
Global stakeholder collaboration
Key Requirements
Must be a Licensed Pharmacist in Japan
Strong analytical and decision-making skills
Ability to work in English reading and writing
Knowledge of Pharmaceuticals and Medical Devices Act