Quality Assurance Officer

il y a 1 jour

Saclay, Île-de-France EXCELYA Temps plein

About the Job

At Excelya, we take pride in embodying the core values of Audacity, Care, and Energy. As a leading player in the healthcare sector, our mission is to ensure quality and compliance in all our clinical research operations.

This mission is part of a strategic "Data Integrity Enabling Program" aimed at strengthening data governance and ensuring full compliance across all R&D activities. The project focuses on deploying a harmonized data integrity risk-management methodology and supporting critical GxP areas (GCP, GLP, GMP).

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.

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