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Job summary
An innovative biotechnology organization in Paris is seeking a QMS Manager to play a crucial role in strengthening the Quality Management System while ensuring compliance with global regulatory requirements. The incumbent will manage QMS processes and lead internal audits, collaborating with R&D, Clinical, and external partners. The ideal candidate has a Bachelor's degree in Life Sciences and significant experience in biotech environments, particularly with GMP and GxP standards. This position offers a unique opportunity to work in a cutting-edge biotech setting.
Qualifications
Significant experience managing a QMS within a biotech or pharmaceutical environment.
Strong knowledge of GMP, GxP, and international regulatory requirements.
Proven experience with regulatory inspections and audits.
Responsibilities
Oversee, maintain, and improve the Quality Management System.
Develop and implement quality policies and procedures.
Lead internal audits and manage document control systems.
Monitor quality performance metrics and report to senior management.
Skills
GMP
GxP
Regulatory requirements
Quality Management System (QMS)
Stakeholder management
Organizational skills
Education
Bachelor's degree in Life Sciences, Biotechnology, or related discipline
Tools
Electronic QMS (eQMS) platforms
Job description
An innovative biotechnology organization in Paris is seeking a QMS Manager to play a crucial role in strengthening the Quality Management System while ensuring compliance with global regulatory requirements. The incumbent will manage QMS processes and lead internal audits, collaborating with R&D, Clinical, and external partners. The ideal candidate has a Bachelor's degree in Life Sciences and significant experience in biotech environments, particularly with GMP and GxP standards. This position offers a unique opportunity to work in a cutting-edge biotech setting.