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

Company:

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

Requirements:

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
E-Mail: kaessner-sohn@trockle-unternehmensberatung.de
Internet: www.trockle-unternehmensberatung.de

 

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