Quality Manager (M/W)
CellProthera is a biotech company based in France (Alsace) developing innovative cell therapy products (ATMP) based on a proprietary bioprocessing technology. A multi-center Phase I/IIb clinical trial is currently on-going in Europe for the treatment of Acute Myocardial Infarct patients. A safety trial has also recently started in Singapore.
We are looking for an experienced Quality Manager to support and develop the implementation of the overall quality system and compliance programs.
- Provide a QA oversight on external suppliers from supplier qualifications, changes in supplier, to quality agreements, in close collaboration with department leaders.
- Write and update Standards Operating Procedures and QMS documentation in compliance with cGMP standards and ensure implementation at third parties.
- Manage deviations, change controls and CAPAs and report monthly KPIs.
- Contribute to Internal and External Audits program.
- Deliver Quality related Training, ensure that Quality Policies are applied across the company and that employees’ qualifications are up-to-date.
- Assist department leaders in the execution and implementation of ad-hoc projects.
- Bachelor’s Degree/equivalent in scientific discipline, ideally in Pharmaceutical, Biotech-, Chemical- or Biological sciences.
- Min. 3 years-experience in a Pharma QA/QC GMP environment.
- Quality Assurance qualifications and working knowledge of cGMPs. Knowledge of GMP for ATMPs is a plus.
- Rigorous, result-oriented, hands-on and autonomous.
- Strong communication and teamwork skills.
- Fluency in English. French conversational.
Applicants should be entitled to work within the European Economic Area (EEA).
If you are interested in this job, please contact Paula Lee (firstname.lastname@example.org)