GCP Quality Manager (m/f) Mologen AG Berlin Planning, preparation and performance or supervision of internal and external audits based on company standards and Good Clinical Practice (GCP) regulations and guidelines;... with new and unique technologies and active substances the biotech company ag is one of the pioneers in the field of immunotherapy alongside a focus on immunooncology also develops immunotherapies for the treatment of infectious diseases 's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need ag is listed on the stock exchange and its headquarters are located in berlin germany the shares of the company are listed on the prime standard at the frankfurt stock exchange (isin de0006637200) for the expansion of our quality management / quality assurance team in berlin-dahlem we are currently looking for a: gcp quality manager (m/f) (full time) we are looking for a candidate with at least 4 years working experience in the pharmaceutical industry and/or contract research organizations you will be in charge of the quality management system of the clinical development and all issues related to the good clinical practice (gcp) of current and future clinical studies your main responsibilities will be: planning preparation and performance or supervision of internal and external audits based on company standards and good clinical practice (gcp) regulations and guidelines generation of audit reports including capa management advise and train employees regarding quality management and gcp supporting inspection readiness activities for regulatory authority gcp inspections both routine and pre-approval inspections of the company and of associated investigator sites maintenance and monitoring of the gcp compliance lead and/or participating in gcp quality improvement projects identify clinical trial related risks and implement mitigation strategies monitoring of updates to current regulations and guidances at regional national and international levels and implementation review quality (qc) audit and maintenance of clinical documentation and submissions (eg study protocols investigator brochures informed consent forms case report forms and study reports) creating and reviewing gcp relevant quality management documents what we expect from you: at least 4 years working experience in the pharmaceutical industry and/or at a contract research organization (cro) several years working experience in a qa regulated environment as well as profound expertise and experience with gcp including auditing comprehensive knowledge of gcp regulations and the ability to interpret and apply gcp standards both domestic and international excellent interpersonal communication and analytical skills willingness for domestic and international travel (up to 30 %) excellent language skills in german and english what we have to offer: challenging professional tasks with creative leeway flexible working hours a competitive compensation and attractive social benefits if you are interested please send your complete application documents including information about your potential start date and your expected salary exclusively electronically to: applications@com should you have questions beforehand please contact mrs arlett killat at killat@com or by telephone at +49 (0)30 8417 8811 we look forward to receiving your application ag human resources c/o arlett killat bewerbung@com tel 030 - 84 17 88- 11 fabeckstr 30 14195 berlin wwwcom QM Prüfverfahren Qualitätsaudit Qualitätsmanagement Qualitätsprüfung Qualitätssicherung Qualitätswesen Automatisierungstechnik Prozessautomatisierung Dokumentation Projektmanagement GCP Quality Manager (m/f) Planning preparation and performance or supervision of internal and external audits based on company standards and Good Clinical Practice (GCP) regulations and guidelines Berlin QM Prüfverfahren Qualitätsaudit Qualitätsmanagement Qualitätsprüfung Qualitätssicherung Qualitätswesen Automatisierungstechnik Prozessautomatisierung Dokumentation Projektmanagement



Die Stellenanzeige GCP Quality Manager (m/f) von Mologen AG wurde zuletzt aktualisiert am 04.03.2016.



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