Head Pharmacist & Quality Leader, Cell Therapy

Sartorius; Lyon; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Sartorius is seeking a Head Pharmacist & Manager of Quality at the Saint-Priest site to lead the pharmaceutical quality system, oversee regulatory compliance, and drive continuous improvement in a GMP environment. This role combines strategic leadership with hands-on regulatory accountability for patient safety.

You will manage a cross-functional quality team and represent the company before ANSM, ensuring all regulatory authorizations are maintained and quality releases are executed for cell

Qualifications

• Pharmacy Doctorate required and registration with Ordre des Pharmaciens.
• Minimum 5 years of leadership experience in GMP-regulated industrial environments.
• Fluency in English and French; other languages a plus.

Responsabilités

• Own the pharmaceutical quality system end-to-end: deviations, complaints, change control, CAPA, and audits.
• Establish and maintain the Quality Policy and customer Quality Agreements.
• Ensure quality capabilities meet EU GMP, cGMP and ICH guidelines.
• Lead management reviews and quality indicators for continuous improvement.
• Qualify and monitor suppliers, subcontractors and service providers.
• Lead regulatory intelligence and implement timely changes.
• Manage crises and communicate effectively with senior management.
• Build and develop the Quality team (technicians and engineers).
• Represent the company before ANSM and other authorities as Head Pharmacist.
• Hold and maintain regulatory authorizations for pharmaceutical activity.
• Certify and release batches including cell banks and intermediates.

Connaissances

GMP expertise

Regulatory leadership

Quality management

Leadership

Project management

Communication skills

Cell therapy knowledge

Biology/pharma background

Formation

Pharmacy Doctorate

Description du poste

Sartorius is seeking a Head Pharmacist & Manager of Quality at the Saint-Priest site to lead the pharmaceutical quality system, oversee regulatory compliance, and drive continuous improvement in a GMP environment. This role combines strategic leadership with hands-on regulatory accountability for patient safety.

You will manage a cross-functional quality team and represent the company before ANSM, ensuring all regulatory authorizations are maintained and quality releases are executed for cell