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R&D Quality Documentation Lead

BOULOGNE BILLANCOURT
il y a 1 jour

About the Job

At Excelya, we uphold the values of Audacity, Care, and Energy in everything we do. We are seeking a dedicated Quality Document Manager to join our Quality Assurance team.

As part of the R&D Quality Assurance team, you will support the Quality Management System (QMS) dedicated to Research and Translational Medicine activities within Preclinical Data Management.

You will contribute to maintaining and improving the quality documentation framework, ensuring compliance with internal policies and applicable regulations. This role offers strong exposure to cross‑functional R&D teams in a structured and scientifically driven environment.

Main Responsibilities

  • Support the implementation and maintenance of the R&D Quality Management System
  • Contribute to drafting, updating, reviewing, and coordinating quality documents (SOPs, MOPs, or equivalent)
  • Ensure alignment of documentation with central quality policies and internal standards
  • Provide guidance to process owners and document owners regarding quality documentation
  • Develop and update training materials related to quality processes
  • Participate in training sessions for R&D staff
  • Monitor the implementation of Corrective and Preventive Actions (CAPA) for assigned projects
  • Contribute to quality metrics follow‑up and documentation traceability

Required Skills

  • Quality Assurance
  • Training
  • Data Management & Analytics
  • R&D

Required Languages

  • English
  • French
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Entreprise
Excelya
Plateforme de publication
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