Quality Management Specialist

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

Résumé du poste

A biotechnology organization in Paris is seeking a QMS Manager to oversee and improve the Quality Management System. The role focuses on ensuring compliance with regulatory requirements and collaboration with various departments. Ideal candidates have a life sciences degree and experience managing a QMS within biotech or pharmaceutical settings. Responsibilities include audit management, and developing quality policies. Join a forward-thinking biotech firm committed to advancing therapeutic developments.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or related.
• Significant experience managing a QMS in biotech or pharmaceutical.
• Strong knowledge of GMP and GxP standards.

Responsabilités

• Own and manage the Quality Management System according to regulations.
• Develop and maintain quality policies, procedures, and documentation.
• Lead internal and partner audits and inspections.

Connaissances

Quality Management System compliance

Regulatory requirements knowledge

Stakeholder management

Communication skills

Formation

Bachelor’s degree in Life Sciences or related

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.