Qa Sr. Manager

Amgen UK

**
Lead qa department operations
Establish gxp quality management system
Ensure compliance with japanese regulations
** Amgen UK is seeking a Senior Manager of Quality Assurance to lead their QA department, ensuring compliance with regulatory standards and driving continuous improvement initiatives. The role requires a strong background in quality assurance, particularly within the pharmaceutical industry, and proficiency in both English and Japanese. **

Job Summary

  • The Senior Manager of Quality Assurance leads the QA department in establishing and maintaining the Quality Management System for Amgen UK.
  • This role is accountable for ensuring compliance with Amgen GxP policies, government regulations, and specifically Japanese Pharmacopoeia requirements.
  • The position involves providing technical guidance for PMDA inspections and managing quality oversight for contract laboratories and logistics providers.

Matching Summary

Match Score: 75

** Amgen UK is seeking a Senior Manager of Quality Assurance to lead their QA department, ensuring compliance with regulatory standards and driving continuous improvement initiatives. The role requires a strong background in quality assurance, particularly within the pharmaceutical industry, and proficiency in both English and Japanese. **

Skills & Requirements

Must-have

  • Lead QA department operations
  • Establish GxP Quality Management System
  • Ensure compliance with Japanese regulations
  • Manage batch release and CAPA processes
  • Oversee contract laboratories and manufacturers

Nice-to-have

  • Experience with biologics and small molecules
  • Strong English and Japanese communication skills
  • Global team collaboration experience
  • Flexible to travel internationally
  • Self-leadership and high integrity

Key Requirements

  • Doctorate +2 years or Masters +4 years or Bachelors +5 years experience
  • Directly related experience in global commercial quality assurance
  • Demonstrated ability to manage partnership alliances
  • Managerial experience leading teams or projects
  • Experience with MNCs and Japanese pharmaceutical companies

Work Rights

Not specified

Tailored Resume

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