Biotech QMS Leader for GMP & Compliance

Meet Life Sciences; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP

GxP

Regulatory requirements

Quality Management System (QMS)

Stakeholder management

Organizational skills

Formation

Bachelor's degree in Life Sciences, Biotechnology, or related discipline

Outils

Electronic QMS (eQMS) platforms

Description du poste

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.