28 Déc [2018-12] Quality Manager – Filled
Quality Manager (M/W) – Filled
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.
Your missions
- 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.
Your profil
- 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 (plee@cellprothera.com)