Clinical Country Quality Manager (CCQM)

We are seeking an experienced Clinical Country Quality Manager (CCQM) to lead and oversee Clinical Quality Management activities across a designated country or cluster. Reporting to the Regional Director, Clinical Quality Management, this role is responsible for driving quality and compliance across clinical trial operations, ensuring adherence to ICH-GCP, local regulations, and global processes.

The CCQM serves as the local quality expert, partnering closely with country operations teams to support process implementation, continuous improvement initiatives, quality control activities, audits and inspections, supplier qualification, and regulatory compliance. This position also plays a key role in identifying training needs, managing quality-related risks, investigating compliance issues, and promoting a culture of quality across the organization.

Key Responsibilities

• Lead country-level Clinical Quality Management activities and quality improvement initiatives.
• Ensure implementation and maintenance of global and local processes, SOPs, and regulatory requirements.
• Oversee Quality Control activities, trend analysis, root cause investigations, and corrective action plans.
• Act as the primary local contact for audits, inspections, and regulatory agency interactions.
• Support training programs and partner with stakeholders to identify development needs.
• Manage supplier quality qualification activities and support compliance and privacy initiatives.
• Collaborate with cross-functional teams to drive operational excellence and quality outcomes.

Qualifications

• Bachelor's degree in a healthcare or life sciences-related field.
• 6-8+ years of clinical research experience, including direct monitoring or oversight of monitoring teams.
• Strong knowledge of Clinical Trial processes, ICH-GCP, and applicable regulatory requirements.
• Experience leading cross-functional projects and driving process improvements.
• Prior experience in Clinical Quality Management, audits/inspections, quality control, or training delivery is highly preferred.
• Excellent leadership, communication, problem-solving, and stakeholder management skills.

Why Join Us?

This is an exciting opportunity to influence quality strategy, support inspection readiness, and drive continuous improvement across clinical research operations while working in a highly collaborative, global environment.
Ideal for senior clinical research professionals who are passionate about quality, compliance, process excellence, and leading impactful initiatives across country operations.