Your Responsibilities:
* Ensure document management, i.e. organize, draft and review documents related to the Company's activities (procedures and instructions),
* check records relating to laboratory activities (protocols, study data, equipment documents, etc.),
* manage corrective, preventive and improvement action plans based on non-conformities, audits and assessment results,
* use, or create when necessary, data analysis tools to evaluate and improve the quality system.
Internal and external audits
* conduct internal audits to assess and monitor the compliance of processes and studies with standards, procedures and protocols,
* conduct audits of service providers involved in the development of drug candidates.
Experience & Qualifications:
* Bac+5 in a scientific field supplemented by training in Quality or equivalent professional experience,
* 3 to 5 years' similar experience in biology, biotechnology and/or the pharmaceutical industry,
* Good knowledge of the normative and regulatory environment applicable to laboratory activities and drug development, including GxP in general,
* Audit training and experience.
* Technical Competencies: ISO standards, GLP, GCLP, ICH, Audits,
* Ability to work in a dynamic environment and meet tight deadlines
* Flexibility in work planning to adapt to program priorities and Company activities
* Travel in Europe and abroad to be planned
* French and English read and spoken.
