Quality Document Manager H/F - Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

At Excelya, we uphold the values of Audacity, Care, and Energy in everything we do. We are seeking a dedicated Quality Document Manager to join our Quality Assurance team.

As part of the R&D Quality Assurance team, you will support the Quality Management System (QMS) dedicated to Research and Translational Medicine activities within Preclinical Data Management.

You will contribute to maintaining and improving the quality documentation framework, ensuring compliance with internal policies and applicable regulations. This role offers strong exposure to cross-functional R&D teams in a structured and scientifically driven environment.

Main Responsibilities

- Support the implementation and maintenance of the R&D Quality Management System
- Contribute to drafting, updating, reviewing, and coordinating quality documents (SOPs, MOPs, or equivalent)
- Ensure alignment of documentation with central quality policies and internal standards
- Provide guidance to process owners and document owners regarding quality documentation
- Develop and update training materials related to quality processes
- Participate in training sessions for R&D staff
- Monitor the implementation of Corrective and Preventive Actions (CAPA) for assigned projects
- Contribute to quality metrics follow-up and documentation traceability

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 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.

At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose. Your challenges become our shared mission. Together, we transform bold ideas into reality-the Excelya way.

Apply today, become an Excelyate!

About You

The ideal candidate will be organized, detail-oriented, and passionate about ensuring high standards in quality documentation. You will thrive in a collaborative environment and embody the values that shape our work ethic at Excelya.

- Experience: Proven experience in quality document management, quality assurance, or regulatory affairs within the pharmaceutical or biotechnology industries.
- Skills: Strong understanding of document control processes, regulatory requirements, and quality management systems; excellent written and verbal communication skills.
- Education: Bachelor's degree in Life Sciences, Quality Assurance, or a related field.
- Languages: Fluent in English and French (written and spoken)