(asso./sr.) Manager, Country Clincial Quality Management
medhunter.de
Ich-gcp and local regulations
Quality control activities
Audit and inspection management
The Country Clinical Quality Manager (CCQM) ensures patient safety, high-quality data, and compliance with company requirements and regulations for all company-sponsored clinical trials
Job Summary
The Country Clinical Quality Manager (CCQM) ensures patient safety, high-quality data, and compliance with company requirements and regulations for all company-sponsored clinical trials.
This role involves implementing local/global processes, identifying improvement opportunities, supporting continuous improvement, and managing audits, inspections, quality control, and local training.
Key responsibilities include acting as a local expert for regulations, managing quality control activities, serving as the primary local contact for audits and inspections, and escalating quality/compliance issues.
Matching Summary
The Country Clinical Quality Manager (CCQM) ensures patient safety, high-quality data, and compliance with company requirements and regulations for all company-sponsored clinical trials.
Skills & Requirements
Must-have
ICH-GCP and local regulations
Quality Control activities
Audit and inspection management
CAPA management
Root Cause Analysis
Nice-to-have
Process improvement initiatives
Cross-functional team leadership
Training coordination
Key Requirements
6-8 years of relevant clinical research experience
Bachelor's Degree or equivalent in a healthcare area