Quality Assurance Manager
Amgen · Tokyo, Japan
QualityFull-timeCompany career page
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Role summary
Amgen seeks a Quality Assurance Manager to oversee quality documentation, batch disposition, and compliance for internal and contract manufacturing operations across Japan. The role requires strategic quality leadership, audit management, and cross-functional collaboration with fluency in Japanese and English.
What they're looking for
- Bachelor's or Master's degree with minimum 6 years quality and compliance experience
- Strong GMP compliance background, preferably in manufacturing or materials management
- Fluent English and Japanese communication skills, written and oral
- Experience in drug substance, drug product, or packaging manufacturing at various scales
- Proven ability to lead audits, manage investigations, and drive quality improvements
- Risk-based decision-making and regulatory activities experience in Japan
- Analytical testing experience including method transfers and stability studies
What you'll be doing
- Review and approve quality documentation including batch records, deviations, and change controls
- Perform batch disposition activities and support lot release processes
- Negotiate quality agreement terms and ensure contract manufacturing site compliance
- Lead supplier audits and manage inspection readiness for contract manufacturing locations
- Drive continuous improvement initiatives across regional manufacturing operations
Privacy & handoff
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