Senior Clinical Quality Manager
Core
Lead design and implementation of local quality management activities, site visits, and quality checks for DevOps teams in China, ensuring compliance with global and local regulations.
Role type
Senior Clinical Quality Manager (Clinical Operations)
Builds
Local procedural documents, quality dashboards, and training programs for DevOps teams
Domain
Healthcare / Clinical Research / China Regulatory Compliance
Required skills
Clinical quality management, China GCP inspections, Study management, Site management & monitoring, Local regulations knowledge, Training program design, Cross-functional project leadership, Data privacy assessment
Preferred skills
Strategic thinking, Risk and crisis management, Change management
Technologies
DevOps, ICH-GCP, Quality & Compliance manuals
Responsibilities
Lead design and implementation of local quality management activities including site visits and in-house checks; Advise DevOps staff on procedural frameworks and international guidelines; Drive development and maintenance of Local Procedural Documents; Coordinate audit strategy and lead trend analysis of audit findings; Lead local training programs from design to execution; Manage clinical compliance activities including data privacy and cross-border data transfer assessments.