Global Quality Systems Coordinator

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.