Clinical Quality Assurance Officer

Excelya Group; Paris; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading mid-size CRO is looking for a candidate to join their Clinical Quality Assurance team. The role includes conducting audits, ensuring compliance with regulations, and supporting teams in a clinical research environment. The ideal candidate will have a strong understanding of GCP, excellent communication skills, and a Bachelor's degree in life sciences or a related field. Fluency in French and English is essential. Join us to grow within an innovative company dedicated to improving healthcare.

Qualifications

• Previous experience or strong understanding of GCP Quality Assurance.
• Fluent in French and English (written and spoken).

Responsabilités

• Conduct internal and external audits related to clinical research.
• Prepare audit plans, perform risk assessments, and document findings.
• Ensure timely and effective implementation of CAPA.
• Support teams during regulatory inspections.
• Review and contribute to SOPs and quality documents.
• Provide training and quality guidance.
• Monitor regulatory and industry updates.
• Participate in continuous improvement initiatives.
• Maintain accurate documentation according to QA standards.

Connaissances

Knowledge of ICH-GCP

Experience in audit conduct

Interpersonal skills

Ability to analyze compliance risks

Formation

Bachelor’s degree in life sciences or related field

Description du poste

About the Job

Join Excelya, where Audacity, Care, and Energy define how we support our clients and how we grow together. We believe in building bold solutions and fostering an inclusive environment where collaboration, responsibility, and personal development are central.

This role is an exciting opportunity to join our Clinical Quality Assurance team. As a key contributor, you will ensure that clinical research activities are conducted in full compliance with international regulations, internal standards, and industry best practices. You will help drive continuous improvement, strengthen our quality culture, and support teams through a stimulating and supportive professional environment.

Main Responsibilities

• Conduct internal and external audits related to clinical research (GCP, investigator sites, vendors, systems).
• Prepare audit plans, perform risk assessments, and document findings in detailed audit reports.
• Follow up on corrective and preventive actions (CAPA) and ensure timely and effective implementation.
• Support teams during regulatory inspections (EMA, ANSM, FDA or other competent authorities).
• Review and contribute to the development of SOPs, quality documents, and clinical processes.
• Provide training and quality guidance to operational teams to reinforce compliance and best practices.
• Monitor regulatory and industry updates (ICH‑GCP, EU regulations, national guidance) and assess their impact.
• Participate in continuous improvement initiatives to strengthen the quality management system.
• Maintain accurate and compliant documentation according to QA standards.

About You

Experience: Previous experience or strong understanding of GCP Quality Assurance in a clinical research environment (pharma, CRO, biotech) is essential.

Skills:

• Solid knowledge of ICH‑GCP, EU CTR, and applicable regulatory frameworks.
• Experience in audit conduct (site, vendor, internal) and CAPA management.
• Ability to analyze compliance risks and propose pragmatic, process‑oriented solutions.
• Strong communication and interpersonal skills to support and guide operational teams.

Education: Bachelor’s degree in life sciences, pharmacy, or a related scientific field (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.