Our client is a France-based pharmaceutical company, specializing in the research, development, and commercialization of tyrosine kinase inhibitors, a new class of targeted therapeutic molecules. It is leading an important clinical development program in oncology, neurology and inflammatory diseases, with 13 Phase 3 clinical studies in 35 countries.
We are looking for a Clinical Trial Quality Assurance Manager.
You will work under the direct responsibility of our Head of Quality Assurance.
You will contribute to our QMS development and our QC plan, audit plan management. You will also contribute to monitor all operations that affect quality, assure the reliability and consistency by checking processes and final output, follow-up the root analysis of non-conformities and associated CAPA plan, facilitate proactive solutions by collecting and analyzing quality data, review current standards and policies, keep records of quality reports, statistical reviews and relevant documentation, ensure all legal standards are met, participate in giving external and internal quality training.
Min 3 years in a similar position
Passed experience in early phase clinical research
Project management skills (organized, can drive multiple streams of information simultaneously in a controlled manner)
Strong knowledge of GxP’s (GLP, GMP, GCP), (Any GxP environment is great, but will be GCP-focused)
Excellent writing skills
Fluent Professional English and French mandatory
Good knowledge of applicable regulations: GCP-ICH, EU and french regulations in clinical research
Good relational skills for implementation of transversal working