# Global Quality Systems Coordinator

> Excelya · Boulogne-Billancourt, France (Hybrid) · Full-time · Posted 2026-07-08

**Workplace:** hybrid

**Department:** Quality - Resourcing

## Description

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.

## Apply

[Apply at Excelya](https://apply.workable.com/excelya/j/948C9CF617/apply)

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