Clinical Country Quality Manager
Fortrea · Guatemala
Descripcion del puesto
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.
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Publicado hace 3 semanas
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Fortrea
Guatemala
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