Qa Manager, External Supply Quality

Amgen Australia Pty Ltd

Singapore, Singapore
**
Global gmp standards compliance
Supplier relationship management
Master batch record review
** Amgen is seeking a QA Manager for External Supply Quality at its Singapore manufacturing facility. The role involves leading quality oversight for contract manufacturing sites in the JAPAC region, ensuring compliance with global standards, and driving continuous improvement. **

Job Summary

  • This role leads quality oversight for Amgen Contract Manufacturing locations across the Japan and Asia Pacific (JAPAC) region to ensure reliable supply of innovative medicines.
  • The successful candidate will act as the primary quality lead for supplier relationships, conducting technical site visits and negotiating quality agreements while ensuring strict adherence to global GMP standards.
  • Amgen offers vast opportunities to learn and move up within a diverse and inclusive community that empowers teammates to bring ideas to the table.

Matching Summary

Match Score: 75

** Amgen is seeking a QA Manager for External Supply Quality at its Singapore manufacturing facility. The role involves leading quality oversight for contract manufacturing sites in the JAPAC region, ensuring compliance with global standards, and driving continuous improvement. **

Skills & Requirements

Must-have

  • Global GMP standards compliance
  • Supplier relationship management
  • Master batch record review
  • Deviation and CAPA approval
  • New product introduction oversight
  • Quality agreement negotiation
  • Contract manufacturer audits

Nice-to-have

  • Synthetics or small molecule experience
  • Analytical testing method transfers
  • Cross-cultural communication skills
  • Risk-based decision-making approach
  • Continuous improvement project leadership
  • Mentoring and coaching capabilities

Key Requirements

  • Doctorate OR Master's degree with 2 years experience
  • Bachelor's degree with 4 years experience
  • Diploma with 8 years experience
  • Experience in drug substance or drug product manufacturing
  • Experience with analytical testing situations

Work Rights

Not specified

Tailored Resume

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