Hybrid Quality Assurance Officer

at Excelya

• Job title: 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, Saclay, France

About the role

• Quality Assurance Officer ensuring quality and compliance in clinical research operations at Excelya. Leading data integrity initiatives and working with R&D teams across prioritized processes for 2025-2026.

Responsibilities

• **Your Responsibilities**
• Deploy the internal Data Integrity Risk Assessment methodology across prioritized R&D processes for 2025–2026.
• Facilitate and co-lead Data Integrity risk-assessment workshops with R&D teams.
• Consolidate workshop outcomes, define action plans, and align them with business stakeholders.
• Track and maintain KPIs/metrics to monitor project progress and Data Integrity deployment.
• Contribute to project management activities, including preparing materials for governance bodies and steering committees.
• Support the creation of communication materials related to Data Integrity initiatives.
• Produce a monthly report summarizing progress, deliverables, and key achievements.
• Collaborate with Quality Assurance and R&D teams to ensure consistency with GxP requirements.

Requirements

• **About You**
• We seek individuals who are detail-oriented, proactive, and committed to ensuring excellence in our clinical research endeavors.
• **Experience:**
• Proven experience with strong experience in data integrity deployment.
• Experience** in change management**, including the ability to adapt methodologies for maximum effectiveness.
• **Skills:**
• Solid knowledge of **GxP regulatory frameworks** (GCLP, GCP, GLP, GMP).
• Strong understanding of **Data Integrity principles (ALCOA/ALCOA+)** and practical implementation in R&D environments.
• Good understanding of **R&D processes** across research, clinical, translational, and CMC domains.
• **Education:** Degree in Life Sciences, Pharmacy, or a related field is required.
• **Languages:** Proficiency in both French and English, with excellent 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.