Head Pharmacist & Manager of Quality (F|M)
Sartorius · Lyon
Join our Quality Management team as Head Pharmacist & Manager of Quality (F|M) and take on a dual strategic and regulatory leadership role at our Sartorius Bio Elpida site in Saint-Priest, a cell therapy-focused service company.Reporting to the Head of Cluster Process Development and Services within the Emerging Business Advanced Therapy Solutions, you will be accountable for the effectiveness of the Pharmaceutical Quality System, ensure regulatory compliance and continuous improvement across the organization, working closely with an international group and matrix organization to support business growth.
Then, you hold personal legal accountability under the French Public Health Code (Article R.5124-36) for the company's pharmaceutical activities and for patient safety.
Grow With Us – Your Responsibilities
As Manager of Quality
- Own the pharmaceutical quality system end-to-end: deviations, complaints, change control, CAPA, and internal, client and external audits and inspections.
- Establish and maintain the Quality Policy and customer Quality Agreements.
- Ensure quality capabilities meet customer, market and regulatory expectations (EU GMP, cGMP, ICH guidelines and other applicable requirements).
- Lead management reviews and quality indicators to drive continuous improvement.
- Qualify and monitor suppliers, subcontractors and service providers.
- Lead regulatory intelligence: track changes in applicable regulations, ensure impact analyses are performed, and drive timely implementation.
- Manage crisis situations and ensure effective escalation of quality issues to senior management and clear communication within the department.
- Build, lead and develop the Quality team (technicians and engineers).
As Head Pharmacist (Pharmacien Responsable)
- Represent the company before the French National Agency for Medicines and Health Products Safety (ANSM) and other competent authorities.
- Hold and maintain all regulatory authorizations required for the company's pharmaceutical activity.
- Confirm, certify and release pharmaceutical and non-pharmaceutical batches, including cell banks, active substances, and intermediate and finished products.
What Will Convince Us
- Doctorate in Pharmacy (or equivalent qualification recognized for appointment as Head Pharmacist under French regulations), with a specialization in biology, cell and gene therapy or a related discipline; registration with the French “Ordre des Pharmaciens”.
- Minimum 5 years of experience managing teams in a GMP-regulated industrial environment.
- Fluency in both English and French required; additional languages are an advantage.
- Strong expertise in EU GMP, cGMP, ICH guidelines and applicable pharmaceutical regulations.
- Technical knowledge of cell and gene therapy manufacturing processes and associated technologies.
- Good understanding of the business model of a service company.
- Proven leadership, rigor and strong communication skills, with a proactive, pragmatic and solution-oriented mindset.
- Demonstrated project management experience within complex, international matrix organizations.
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers