About the Job
At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Clinical Quality Manager. This pivotal role focuses on overseeing the quality management system within clinical operations to ensure compliance with regulatory requirements and continuous improvement of clinical processes.
As a Clinical Quality Manager, you will lead the development and implementation of quality strategies, manage audits and inspections, and collaborate closely with cross-functional teams to uphold the highest standards in clinical research.
Key Responsibilities
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Define, harmonize, and maintain quality procedures (SOPs) and ensure their effective implementation across teams.
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Lead and manage internal and external GCP audits, including preparation, execution, and follow‑up of CAPA plans.
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Ensure alignment with Global Quality teams and contribute to the consistency of processes and standards across the organization.
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Participate in quality comittees and drive continuous improvement of quality systems and processes.
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Lead, coach, and develop a team of quality professionals, supporting their performance and growth.
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Drive the evolution of working methods toward more efficient, structured, and compliant practices.
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Promote a strong quality culture, combining regulatory rigor with a pragmatic and business-oriented approach.
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Challenge existing processes and implement improvements to enhance performance and compliance.
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Prioritize and manage activities in a fast‑changing environment while ensuring regulatory requirements are met.
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Contribute to the structuring and scaling of the organization in a growth context.
Requirements
About You
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Strong and extensive experience in clinical quality management within pharmaceutical, biotech, or CRO environments.
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Strong knowledge of ICH-GCP guidelines, EU CTR, FDA regulations, and other relevant standards.
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Proven leadership skills with experience managing audit programs and quality improvement projects.
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Excellent communication, organizational, and problem-solving skills.
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Scientific degree in life sciences, pharmacy, or related field; advanced degree is a plus.
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Fluency in English and French, both written and spoken.
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique.
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
