Hybrid Clinical Quality Assurance Officer

at Excelya

• Job title: Clinical Quality Assurance Officer
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Paris, France

About the role

• Clinical Quality Assurance Officer ensuring compliance with GCP regulations and best practices in clinical research. Conducting audits and training to foster quality assurance culture in healthcare.

Responsibilities

• **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.

Requirements

• **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).

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.