Country Clinical Quality Manager

Posted Yesterday
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2 Locations
In-Office or Remote
Senior level
Biotech
The Role
Leads country-level clinical quality management across clinical trial operations, ensuring compliance with ICH-GCP, local regulations, SOPs, and global processes. Oversees quality control, trend analysis, investigations, corrective actions, audits, inspections, supplier qualification, training, and compliance initiatives. Partners with cross-functional country operations teams to manage risks, improve processes, support inspection readiness, and promote a strong quality culture.
Summary Generated by Built In
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.

Learn more about our EEO & Accommodations request here.

Skills Required

  • Bachelor's degree in a healthcare or life sciences-related field
  • 6-8+ years of clinical research experience
  • 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
  • Experience in Clinical Quality Management, audits or inspections, quality control, or training delivery
  • Leadership, communication, problem-solving, and stakeholder management skills
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The Company
HQ: Durham, NC
10,811 Employees

What We Do

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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