(Asso.) Clinical Quality Manager
Core
Lead design and implementation of local quality management activities, site visits, and in-house quality checks to ensure drug and non-drug projects are inspection-ready.
Role type
Senior Clinical Quality Manager (R&D Clinical Operations)
Builds
Local quality management activities, procedural documents, training programs, and audit strategies for DevOps teams.
Domain
Healthcare / Clinical Research / China Regulatory Compliance
Required skills
China GCP inspection knowledge, Study Management, site management & monitoring, local regulations, quality metrics analysis, audit strategy design, training program execution, data privacy assessment, cross-border data transfer assessment
Preferred skills
Risk and issue management, change management
Technologies
DevOps, ICH-GCP, Quality & Compliance manual documents
Responsibilities
Lead design and implementation of local quality management activities including site visits and in-house checks; Provide advice on AZ procedural framework and international guidelines; Drive development and maintenance of Local Procedural Documents; Act as DevOps contact with QA for audit strategy and findings resolution; Lead local training platform and programs; Lead DevOps clinical compliance management including data privacy and cross-border data transfer assessments.