(sr.) Clinical Quality Manager

AstraZeneca

Multiple Locations
**
Ich-gcp
Local regulations
Clinical quality management
** The Clinical Quality Manager position at AstraZeneca seeks a candidate with extensive experience in clinical quality management and a strong understanding of GCP regulations, particularly in China. The role involves leading quality management activities, ensuring compliance, and driving continuous improvement within the DevOps framework. **

Job Summary

  • The Clinical Quality Manager is responsible for providing quality and compliance advice as well as planning and implementing quality management activities to enable the delivery of drug and non-drug projects.
  • Lead the design and implementation on assigned local quality management activities, including performing accompanied site visits, in-house quality checks and provide local management team with quality metrics and dashboard in DevOps.
  • Drive the development, publication, training, implementation, maintenance and archiving of Local Procedural Documents, ensuring compliance with global Clinical Procedural Documents management requirements.

Matching Summary

Match Score: 75

** The Clinical Quality Manager position at AstraZeneca seeks a candidate with extensive experience in clinical quality management and a strong understanding of GCP regulations, particularly in China. The role involves leading quality management activities, ensuring compliance, and driving continuous improvement within the DevOps framework. **

Skills & Requirements

Must-have

  • ICH-GCP
  • local regulations
  • clinical quality management
  • DevOps staff support
  • audit strategy design

Nice-to-have

  • risk and issue management skills
  • positive approach to change
  • continuous optimization
  • strong results orientation

Key Requirements

  • Bachelor’s degree in healthcare-related field
  • At least 6 years experience in R&D Clinical Operations
  • 2 years experience in clinical quality management
  • Solid knowledge and experience in China GCP inspections
  • Fluent spoken and written English

Work Rights

Not specified

Tailored Resume

Cover Letter