Associate Director (gn) Quality Assurance Operations

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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, collaborating 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:

  •  Representation and strategic decisions for QA at project team meetings and regular calls with vendors
  • Continuous improvement of our internal quality management system based on LEAN principles
  • Write/review Quality Assurance SOPs, and review of SOPs and controlled documents related to IMP topics
  • Write/review Quality Agreements
  • Provide expert advice in GMP (secondary packaging) and GDP (storage & distribution) to MorphoSys internal procedures within relevant departments (e.g. Global Supply Chain, Clinical Operations, CMC)
  • Provide IMP-related GDP/GMP support, advice, education and training to other departments involved in clinical trials and GDP/GMP QA activities
  • Manage GDP/GMP deviations, changes, and complaints occurring at external Contract Packaging and Transport Organizations and CAPA follow-up
  • Support preparation and active participation in authority inspections
  • Perform selection and qualification of new GDP/GMP vendors
  • Plan, perform and follow-up audits of GDP/GMP vendors

Job Qualifications:

  • Sound knowledge in international regulations and guidelines EU / FDA cGMP regulations, GDP guidelines, ICH etc.
  • Familiar with all GMP/GDP aspects relevant for set-up of clinical trials
  • Well-organized, structured person with attention to detail
  • Excellent communication skills, fluent in English (written and spoken)
  • Flexible, highly motivated, with strong organization skills
  • Works collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills
  • Able to work independently and solution-oriented
  • Excellent application of office software (Word, Excel, PowerPoint and SharePoint)
  • Experience with VEEVA or other Quality Management systems is desirable

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 necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg