Director International Quality Assurance GCP (m/f/d) - home-based or office-based


Our client is an internationally operating contract research organization – the holder of the position can work home-based or office-based (NRW)


Main tasks:

  • Further development and control of the companys’ international quality assurance system on corporate level
  • Support of the companys’ international and national project operations providing guidance and training on relevant GCP regulations and guidelines.
  • Monitoring and optimization of a written QA plan on internal systems and procedures as well as study specific requirements, if applicable 
  • Training of companys’ staff on ICH GCP, CPMP, EMEA and FDA guidelines 
  • Conduct of Quality Assurance audits on an international level for Phase I-IV clinical studies at clinical sites with subsequent report of results to companys’ project team and management and sponsor, if applicable.  
  •  Interaction with involved teams after Quality Assurance audits to ensure that corrective actions are taken and to bring QA observations to closure.
  • Assessment of compliance of study management and clinical sites with ICH, government agency regulations/guidelines, as well as companys’ policies, procedures and study specific regulations / protocols.
  • Assistance with sponsor audits and regulatory inspections, follow up of respective audit reports
  • Team leadership of national and international QA colleagues to ensure consistency and standardization in the company for QA policies and procedures


Medical or scientific education or other career path leading to the tasks of the position; experience in clinical development / clinical research; experience in clinical quality assurance and in conducting or preparing audits at trial sites; very good knowledge of ICH / GCP, CPMP, EMA and FDA guidelines and regulations; ability to work independently; good communication skills; very good knowledge of English; ability to work in a culturally diverse environment; willingness to travel


Contact person:

Dr. med. Monika Kässner-Sohn
Senior Partner
TROCKLE Unternehmensberatung
Neumannstr. 17
D- 40235 Düsseldorf
Tel.: + 49 (0)211/95756914