(asso./sr.) Manager, Country Clincial Quality Management
Laboratory Animal Management Association
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 Country Clinical Quality Manager serves as the primary local point of contact for R&D Quality Assurance and regulatory agencies during audits and inspections.
This position requires leading continuous quality improvement activities and managing corrective and preventive actions (CAPAs) based on root-cause analysis.
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.
Skills & Requirements
Must-have
6-8 years clinical research experience
Deep knowledge of ICH-GCP and local regulations
Experience managing audits and inspections
CAPA management and root cause analysis skills
Leading cross-functional teams in quality
Nice-to-have
Experience in country operations preferred
Background in clinical trials monitoring
Experience coordinating training sessions
Project management certification or practice
Strong conflict resolution expertise
Key Requirements
Bachelor's Degree in relevant health care area
Minimum 6-8 years relevant clinical research experience
No VISA Sponsorship available
Direct field monitoring or oversight experience required