Lead qa department and maintain quality management system
Ensure compliance with amgen gxp and government regulations
Manage batch release capa change control and deviation processes
The Senior Manager of Quality Assurance leads the QA department and plays a crucial role in establishing, implementing, and maintaining the Quality Management System
Job Summary
The Senior Manager of Quality Assurance leads the QA department and plays a crucial role in establishing, implementing, and maintaining the Quality Management System.
This role is accountable for compliance with Amgen GxP policies and government regulations while managing critical GxP processes such as Batch Release, CAPA, and Change Control.
The position requires providing technical guidance for PMDA inspections and contributing to quality deliverables for Japan product launches and lifecycle events.
Matching Summary
The Senior Manager of Quality Assurance leads the QA department and plays a crucial role in establishing, implementing, and maintaining the Quality Management System.
Skills & Requirements
Must-have
Lead QA department and maintain Quality Management System
Ensure compliance with Amgen GxP and government regulations
Manage batch release CAPA change control and deviation processes
Provide guidance for PMDA inspections in Japan
Oversee contract laboratories distributors and logistics providers
Nice-to-have
Experience with biologics and small molecule solid oral dosage forms
Strong verbal and written communication skills in English and Japanese
Flexible to travel internationally as needed
Self-leadership with high personal integrity and application of values
Ability to effectively articulate ideas with all organizational levels
Key Requirements
Doctorate +2 years or Masters +4 years or Bachelors +5 years experience
Directly related experience in quality assurance in global commercial operations
Demonstrated ability to manage partnership alliances and negotiate contracts
Managerial experience directly managing people or leading teams and projects
Experience with Multi-National corporations and Japanese pharmaceutical companies
Experience working with Investigational Medicinal Products and commercial products
Knowledge of regulatory authority inspection processes and confidential quality assurance