(asso./sr.) Manager, Country Clincial Quality Management
microsatsystems.biz
Not specified; not specified; not specified
6-8 years clinical research experience
Deep knowledge of ich-gcp and local regulations
Experience managing audits and inspections
The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all sponsored clinical trials
Job Summary
The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all sponsored clinical trials.
The incumbent acts as the primary local point of contact for R&D Quality Assurance and Regulatory Agencies during audits and inspections.
Responsibilities include leading continuous quality improvement activities, managing Corrective and Preventive Actions (CAPAs), and overseeing local training initiatives.
Matching Summary
The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all sponsored clinical trials.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
6-8 years clinical research experience
Deep knowledge of ICH-GCP and local regulations
Experience managing audits and inspections
Root cause analysis and CAPA management
Leading cross-functional teams in quality
Nice-to-have
Experience in Country Operations preferred
Project management and continuous improvement skills
Training coordination and delivery capabilities
Supplier qualification and assessment experience
Strong communication in international environment
Key Requirements
Bachelor's Degree in relevant health care area
Minimum 6-8 years relevant clinical research experience
Direct field monitoring or management oversight experience