GCP Quality Manager
My client is an independent research-based biotechnology company in Germany who are growing sustainable pipeline of antibody therapeutics targeting solid cancers with high medical need and large market potential. They are looking for a GCP Quality Assurance Manager to join them at their site in west Germany
- Quality assurance of clinical trials in Phases I-III, pharmacovigilance activities, as well as clinic-accompanying biomarker programs
- development of the existing quality system in accordance with GCP area of ??the development of clinical research
- support to the creation and implementation of SOPs (Standard Operating Procedures) and in the development and maintenance of quality documents
- Planning, preparation and execution of internal and external audits (CROs, suppliers, etc.) in the GCP area.
- Creation of audit reports and tracking (CAPA)
- ensure continuing and corporate GCP-compliant training / training of all employees
- Successfully completed a science degree
- Several years of experience in clinical research experience in quality assurance activities for clinical development, including auditing of systems, processes and services
- Prior expeirence in Oncology is advantageous.
- Excellent knowledge of all relevant international and national regulations and regulatory requirements
- Fluent in English and German written and spoken
- Ability to work precisely and in depth detail
If you or anyone you know might be interested in this role- please do not hesitate to contact Reesa Berry on +441483 397070 or send an email to firstname.lastname@example.org