Beschreibung
For a project with our client in Bern, we are looking ASAP for a Quality Assurance Manager.
Tasks:
*Provides support to the entire R&D organization by maintaining and ensuring proper training and adherence to ICH-GCP (International Conference on Harmonisation- Good Clinical Practice), SOPs (Standard Operating Procedures), laws, policies, and local quality systems.
*Development and maintenance of a quality management system for clinical trials
*Ensure development, implementation and maintenance of local procedures that can be used in both countries, taking into account country specific differences and synergies between countries
*Development and training in the area of international GCP regulations policies and SOPs and liaise with international training department
*Maintain audit archive, act as point of contact for GCQA department and facilitate in preparation of corrective action plans.
*Discuss audit findings and implement action in order to avoid re-occurrence
*Assure adherence to clinical trial insurance process and compliance with local law of insurance policy
Profile/qualifications:
*Bio-medical degree at university level
*Long term experience in clinical trials
*Has a good knowledge of the clinical trial environment in Belgium, the Netherlands and Luxembourg including local laws, codes of conduct and policies
*Is strong in communication ensuring good customer relations both internally as well with external parties and government agencies
*Has leadership skills to ensure compliance with guidelines/SOP
*Proficient in German and English
*Active member of a professional development organisation in the field of clinical trials/quality management
Are you interested in this position? Then we are looking forward to receiving your application.