Thermo Fisher Scientific UK is seeking a QA Manager in Japan to lead quality assurance, manufacturing control, and safety management activities for their product portfolio, which includes in vitro diagnostics and medical devices. The role requires strong communication skills, proficiency in English, and knowledge of QMS and the PMD Act, with responsibilities including overseeing manufacturing sites and ensuring compliance with regulatory standards
Job Summary
The role involves planning and driving overall quality assurance, manufacturing control, and safety management activities for handled products and services.
Candidates must ensure compliance with QMS, GVP, and the Pharmaceuticals and Medical Devices Act (PMD Act) while fostering a strong quality culture.
The position requires overseeing domestic manufacturing sites and laboratories while maintaining effective communication with overseas partners and regulatory authorities.
Matching Summary
Match Score: 85
Thermo Fisher Scientific UK is seeking a QA Manager in Japan to lead quality assurance, manufacturing control, and safety management activities for their product portfolio, which includes in vitro diagnostics and medical devices. The role requires strong communication skills, proficiency in English, and knowledge of QMS and the PMD Act, with responsibilities including overseeing manufacturing sites and ensuring compliance with regulatory standards.
Skills & Requirements
Must-have
Knowledge of QMS and GVP frameworks
Understanding of PMD Act regulations
Experience with risk assessment and CAPA
Ability to oversee manufacturing sites
Proficiency in English communication
Nice-to-have
Strong coaching and training skills
Proactive regulatory change monitoring
Cross-functional leadership experience
Evidence-based decision making ability
Key Requirements
Knowledge of QMS, GVP, and PMD Act
Proficiency in English language skills
Experience in pharmaceutical or medical device sectors