Senior Manager, Quality Assurance, Japan

Ultragenyx

Remote
**
Japanese gmp and gqp compliance
Batch disposition
Sop authoring and revision
** Ultragenyx is seeking a Senior Manager for Quality Assurance in Japan, responsible for overseeing QA operations to support product launches and compliance with Japanese regulations. The role emphasizes collaboration with various departments to ensure quality standards are met while fostering a supportive and inclusive company culture. **

Job Summary

  • The Senior Manager, Quality Assurance Japan, leads day-to-day QA operations to sustain product launch and commercial activities, ensuring alignment with Japanese GMP and GQP.
  • Responsibilities include performing batch disposition, overseeing domestic product testing, and managing quality processes like change management and deviations.
  • The role collaborates with various departments to ensure a safe and effective supply of products and supports the establishment of the local QA support model.

Matching Summary

Match Score: 75

** Ultragenyx is seeking a Senior Manager for Quality Assurance in Japan, responsible for overseeing QA operations to support product launches and compliance with Japanese regulations. The role emphasizes collaboration with various departments to ensure quality standards are met while fostering a supportive and inclusive company culture. **

Skills & Requirements

Must-have

  • Japanese GMP and GQP compliance
  • batch disposition
  • SOP authoring and revision
  • change management
  • deviation and CAPA management
  • product quality complaint investigations

Nice-to-have

  • rare disease patient focus
  • collaborative ecosystem
  • supportive and inclusive environment

Key Requirements

  • Experience in QA operations
  • Knowledge of Japanese GMP and GQP
  • Experience with batch disposition
  • Experience with quality processes (change management, deviations, CAPA)

Work Rights

Not specified

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