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 Systems coordinator, you will be responsible for implementing & maintaining relevant QMS to assure the Commercial Operations groups are fully compliant and efficient with Global GxP’s

Your Main responsibilities :

• Define and oversee the Quality Management System (QMS) for Commercial Operations in collaboration with GxP-related functions (Medical Affairs, Pharmacovigilance, Regulatory Affairs, Supply Chain, etc.).
• Act as the Commercial Operations representative in the development and maintenance of global quality standards, procedures, and Quality Technical Agreements (QTAs).
• Lead the deployment, harmonization, and continuous improvement of QMS processes across global and local organizations, affiliates, and business units.
• Manage quality documentation processes and support process owners, authors, and users through document review systems and training initiatives.
• Ensure ongoing GxP compliance, identify gaps, and drive remediation plans, corrective actions, and preventive actions (CAPAs).
• Support audit and inspection readiness activities, coordinate responses, and ensure effective follow-up of inspection and audit findings.
• Promote a strong quality and risk management culture, maintaining risk registers and driving continuous improvement initiatives.
• Develop and oversee GxP training programs and Quality Management Reviews to ensure organizational competence and compliance.
• Coordinate with sites, functions, and partners to resolve quality issues, manage deviations and changes, and support crisis prevention and management activities.
• Oversee quality activities involving external partners, including supplier oversight, product complaint management, QTA negotiation and management, and timely communication of APQRs to MAHs.

Requirements

• Scientific degree in Life Sciences, Pharmacy, Chemistry, Biotechnology

• Strong experience in Quality Management Systems (QMS) and GxP compliance within pharmaceutical, biotech, or healthcare environments.
• In-depth knowledge of GxP regulations, quality standards, risk management principles, and quality governance frameworks.
• Proven expertise in designing, deploying, and continuously improving quality processes across global and local organizations.
• Solid experience supporting regulatory inspections, audits, CAPA management, deviation management, and inspection readiness programs.
• Strong understanding of quality documentation management, including procedures, policies, quality agreements (QTAs), and document control systems.
• Demonstrated ability to lead cross-functional quality initiatives and collaborate effectively with Medical Affairs, Regulatory Affairs, Safety, Supply Chain, affiliates, and external partners.
• Strong project management, stakeholder management, communication, and problem-solving skills, with a focus on continuous improvement.
• Fluency in English and French, with excellent written and verbal communication skills.

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.