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Clinical Country Quality Manager

Fortrea · Guatemala

Senior 🇬🇧 English
clinical trial processes regulatory compliance quality control

Description du poste

About the role

We are looking for an experienced Clinical Country Quality Manager (CCQM) to lead quality management activities across a designated country or cluster. Reporting to the Regional Director, Clinical Quality Management, you will ensure compliance with ICH‑GCP, local regulations, and global processes while fostering a culture of quality.

Key responsibilities

  • Lead country‑level clinical quality management and continuous improvement initiatives.
  • Implement and maintain global and local SOPs, processes, and regulatory requirements.
  • Oversee quality‑control activities, trend analysis, root‑cause investigations and corrective‑action plans.
  • Serve as the primary local contact for audits, inspections and regulatory agency interactions.
  • Support training programs and identify development needs with stakeholders.
  • Manage supplier quality qualification and privacy compliance activities.
  • Collaborate with cross‑functional teams to drive operational excellence.

Required profile

  • Bachelor’s degree in a healthcare or life‑sciences field.
  • 6‑8+ years of clinical research experience, including monitoring or oversight of monitoring teams.
  • Strong knowledge of clinical trial processes, ICH‑GCP and applicable regulatory requirements.
  • Proven experience leading cross‑functional projects and driving process improvements.
  • Excellent leadership, communication and stakeholder‑management skills.

Required skills

  • ICH‑GCP knowledge
  • Clinical trial process expertise
  • Regulatory compliance understanding
  • Quality‑control and audit management

What we offer

  • Opportunity to influence quality strategy and inspection readiness.
  • Collaborative global environment with impact across country operations.
  • Career growth for senior clinical research professionals.

Questions fréquentes

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Fortrea

Guatemala