Your tasks Supports the responsible management in strategic planning and decision making Identifies compliance gaps, potential or actual, as well as options for compliant outcomes and risk mitigation and drives implementation across functional areas Consults and gives direction on quality assurance and GCP compliance questions from all functional areas involved in clinical trials Conducts investigational site, vendor, system and process audits Prepares and supports clinical trial teams and investigational sites before, during, and after regulatory inspections Assists and represents Quality Assurance during Regulatory Inspections from e.g. local authorities, EMA, FDA or PMDA Your profile Bachelor’s degree preferably in physical science, life science, pharmacy or equivalent experience required. At least 3 – 5 years experience of Pharmaceutical Industry in GCP Quality Assurance (strongly preferred), Clinical Operations or Clinical Compliance Function Thorough understanding/knowledge of GCP requirements Able to work independently and manage priorities, as well as operate as team member Solution oriented and able to present information in an objective manner that supports compliance and operational success Collaboration and partnering at all levels of the organization to accomplish deliverables and meet quality standards Excellent written and verbal communication skills in English and German Willingness to travel 10 – 15 %