Quality Management Specialist

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, clinical-stage biotechnology organization focused on developing gene- and cell-based therapies for serious diseases is seeking an experienced QMS Manager. This role offers the opportunity to play a pivotal part in strengthening and evolving the Quality Management System within a highly regulated, cutting-edge biotech environment.

The QMS Manager will be responsible for overseeing, maintaining, and continuously improving the Quality Management System to ensure compliance with global regulatory requirements. The role will work closely with R&D, Clinical, Manufacturing, Regulatory Affairs, and external partners to support development and commercialization activities.

Key Responsibilities

• Own and manage the Quality Management System in compliance with applicable regulations and standards (e.g. GMP, GxP, ISO standards).
• Develop, implement, and maintain quality policies, procedures, and controlled documentation.
• Manage QMS processes including deviations, CAPAs, change control, risk management, and training.
• Lead internal audits and support health authority and partner audits and inspections.
• Oversee document control systems and ensure training compliance across the organization.
• Ensure effective quality oversight of external vendors, CMOs, and partners.
• Monitor quality performance metrics and report QMS status to senior management.
• Promote a culture of quality, compliance, and continuous improvement across the company.

Required Experience & Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or a related discipline.
• Significant experience managing a QMS within a biotech, pharmaceutical, or advanced therapy environment.
• Strong knowledge of GMP, GxP, and relevant international regulatory requirements.
• Proven experience supporting regulatory inspections and audits.
• Hands-on experience with electronic QMS (eQMS) platforms.
• Excellent organizational, communication, and stakeholder management skills.
• Experience in gene therapy, cell therapy, or advanced therapy medicinal products (ATMPs).
• Experience working in a clinical-stage or growing biotech company.