Senior Manager (gn) Quality Assurance IT

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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:

  • Plan, conduct, follow up IT  audits of GxP relevant computer systems at Contract Manufacturing Organizations (CMO), and Contract Research Organizations (CROs)
  • Plan, conduct and follow up internal audits of in-house GxP relevant computer systems and IT infrastructure
  • Host and follow-up authority inspections
  • Supporting Computer System Validation projects in house
  • Quality Assurance oversight of  Computer System Validation projects
  • Write & review SOPs
  • Support continuous improvement projects
  • Provide QA related CSV support, advice, and training to internal departments and stakeholders

Requirements:

  • At least 5 years of professional experience as Quality Assurance and  Computer System Validation in pharmaceutical/biotech industry
  • Experience in software validation projects such as eTMF, statistics and EDC software etc.
  • Experience as auditor
  • Expert knowledge of national and international regulations and standards, e.g. 21 CFR Part 11, Annex 11, GAMP 5
  • Good knowledge of relevant in GMP and GCP regulations/guidelines
  • Well-organized, structured person with attention to detail
  • Excellent communication skills, fluent in German and English (written and spoken)
  • Used to work in  interdisciplinary and intercultural teams
  • Team player with assertive skills, when required
  • Able to work independently and solution-oriented
  • Excellent application of office software (Word, Excel, PowerPoint and SharePoint)

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