Why Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.Heres what makes us unique !We are a young, ambitious health company representing 900 Excelyates, driven to become Europes leading mid-size CRO with the best employee experience. Our one-stop provider service modeloffering full-service, functional service provider, and consultingenables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patients 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.About the JobJoin 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.The mission is carried out within the Computerized Systems Quality Risk Management Division of RD Quality Assurance. This division is responsible for ensuring Gx P compliance and validation of computerized systems used throughout the RD process.Main ResponsibilitiesManage CSV activities in Clinical Development, Pharmacovigilance, and Regulatory Affairs, ensuring Gx P compliance.Define validation strategies and review system documentation to support system integrity.Implement and maintain system compliance with standards like GAMP 5 and 21 CFR Part 11.Apply a risk-based approach to validation, focusing on safety, data protection, quality, and reliability.Oversee outsourced validation, including task definition, deliverable review, and adherence to procedures.Provide guidance and training on computerized system validation to internal teams.Conduct risk assessments and reviews, and support audits, vendor evaluations, and regulatory inspections.Implement CAPAs and monitor regulatory changes impacting systems and validation processes.At Excelya, taking audacious steps is encouraged, so were looking for individuals who are ready to grow with us and share our values.Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum yearstalent matters most to us!)Skills: Strong organizational abilities, problem-solving mindset, and excellent communication skillsEducation: Strong knowledge of pharmaceutical regulations, especially Gx P standards (GCP, GVP, GCLP, GLP, GMP, RQA). Compliance with CSR (Corporate Social Responsibility) principles and policies.Languages: Fluency in English and French, with the ability to contribute to meetings and create documentation in both languagesHybrid work model: Remote work allowed, but ideally 50% on-site or at least 2 days/month at Saclay.