About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Activities
- Review QA documentation related to clinical trials
- Ensure completeness of clinical and quality records
- Assess and track complaints from CROs and sites
- Review audit reports and monitor follow-ups
- Manage SCARs (Supplier Corrective Action Requests)
- Support CAPA implementation and closure
- Follow up on non-conformities (NCFOs)
- Oversee QA documentation for clinical development
- Support GCP inspection readiness (EMA, ANSM, FDA)
- Ensure compliance with GCP and internal SOPs
- Perform QA gap analyses and suggest remediations
- Follow up on audit findings and CAPAs
- Coordinate with internal stakeholders (ClinOps, RA, PV)
- Contribute to QA process improvements and mock inspections
About You
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
- Experience: 5 years of proven experience in Clinical QA in a sponsor environment, experience preparing for regulatory GCP inspections, familiar with audit processes and CAPA management
- Skills: Strong knowledge of GCP and clinical trial regulations, excellent organizational and documentation review skills, ability to work autonomously and proactively, strong communication and collaboration skills
- Education: Degree in Life Sciences or related field (BSc, MSc, PharmD, or equivalent)
- Languages: Fluent in French and English (written and spoken)
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.
