MorphoSys's mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

Your Responsibilities:

  • Plan, perform and follow-up audits of CROs, external laboratories, clinical trial sites
  • Hosting and follow-up of authority inspections
  • Plan, perform and follow-up audits of in house GCP systems including document audits
  • Write / review Quality Assurance SOPs
  • Provide expert advice to MorphoSys internal procedures within relevant departments (e.g. Clinical Operations, Clinical Development, Drug Safety, Pharmacovigilance)
  • Ensure continuous improvement of our internal quality management system
  • Provide support, advice, education and training to other departments involved in clinical trials and drug safety activities

Your Requirements:

  • University Degree with a minimum of five years of professional experience in GCP Quality Assurance within pharmaceutical and / or biotech industry
  • Experience in hosting and following-up of authority inspections including pre-approval inspections
  • Sound knowledge in international regulations and guidelines (EU / FDA regulations, ICH-GCP etc.)
  • Strong communication skills both verbally and written
  • Team player with well-developed interpersonal abilities
  • Strong problem solving and negotiation abilities
  • Flexible, highly motivated, with strong organization skills
  • Fluent in English
  • Ability to travel

We offer:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses
Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning - even helping you move if neccessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg
Ähnliche Stellenanzeigen um Planegg im Bundesland Bayern
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