Qualified Person / Quality Assurance GMP (gn)

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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:

  • Leading a team of Quality Assurance GMP Managers
  • Reporting to VP, Head of Global QA & Internal Audit
  • Performing the task as a Qualified Person in accordance with § 14 AMG (German drug law) for certification of externally manufactured medicinal products
  • Overseeing the management of deviations, changes, out-of-specifications occurring at CMOs
  • Perform QP batch certification of commercial and investigational medicinal product according to EU GMP Guidelines, Annex 16
  • Assessment of APR/PQRs
  • Conduct and follow-up of audits at CMOs
  • Host and follow-up of authority inspections
  • Support continuous improvement of our internal Quality Management System
  • Write / review Quality Assurance SOPs
  • Setting up of Quality Agreements
  • Provide expert advice to MorphoSys internal procedures within relevant departments (e.g. CMC, Pharmacovigilance, Supply Chain Management, Regulatory Affairs)
  • Provide support, advice, education and training to other departments involved in oversight of manufacturing and distribution activities

Job Qualifications:

  • University Degree as a pharmacist with a minimum of several years of professional experience in working as a QP and in GMP Quality Assurance within pharmaceutical and / or biotech industry
  • Qualification as a Qualified Person (QP) in accordance with §15 German Drug Law and article 48 of EU Directive 2001/83
  • In depth knowledge of all aspects of manufacturing and testing processes of biopharmaceuticals
  • Experience in leading a team of QA experts
  • Experience in setting up systems and processes for oversight of commercial drug product manufacturing activities
  • Experience in hosting and following-up of authority inspections including pre-approval inspections
  • Excellent knowledge in national and  international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH 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 and assertive skills
  • Fluent in English and German
  • 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 necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg