The Clinical Quality Manager is responsible for providing quality and compliance advice to enable the delivery of drug and non-drug projects according to agreed quality standards
Job Summary
The Clinical Quality Manager is responsible for providing quality and compliance advice to enable the delivery of drug and non-drug projects according to agreed quality standards.
This role involves leading the design and implementation of local quality management activities, including site visits, in-house checks, and audit strategy coordination.
The position requires acting as a quality expert to advise DevOps staff on resolving findings from audit and inspection reports while ensuring compliance with international guidelines like ICH-GCP.
Matching Summary
The Clinical Quality Manager is responsible for providing quality and compliance advice to enable the delivery of drug and non-drug projects according to agreed quality standards.
Skills & Requirements
Must-have
Bachelor's degree in healthcare-related field
6 years experience in R&D Clinical Operations
2 years experience in clinical quality management
Solid knowledge of China GCP inspections
Fluent spoken and written English
Nice-to-have
Risk and issue management skills
Positive approach to change management
Ability to drive cross functional projects
Key Requirements
Bachelor's degree in healthcare or equivalent
At least 6 years in R&D Clinical Operations
Minimum 2 years in clinical quality management
Deep understanding of China GCP and local regulations
Right to work in the country where role is advertised