Wir haben zum nächstmöglichen Zeitpunkt folgende Position zu besetzen:

Senior Manager (gn) Quality Assurance GMP/GDP

Ihre Verantwortungsbereiche:

  • Plan, perform and follow-up audits of CMOs, Warehouses, Distributors
  • Host and follow-up authority inspections
  • Plan, perform and follow-up audits of in house GMP & GDP systems including document audits
  • Ensure continuous improvement of our internal Quality Management System and support the adaptation of the System to commercial drug supply requirements in USA and Europe
  • Write / review Quality Assurance SOPs
  • Provide expert advice to MorphoSys internal procedures within relevant departments (e.g. CMC, Pharmacovigilance, Supply Chain Management)
  • Provide support, advice, education and training to other departments involved in oversight of manufacturing and distribution activities
  • QA related management of Deviations, Changes, Out-of-Specifications occurring at CMOs, and CAPA follow-up

Sie bringen idealerweise folgende Voraussetzungen mit:

  • University Degree with a minimum of five years of professional experience in GMP and GDP Quality Assurance within pharmaceutical and / or biotech industry
  • Experience in setting up systems and processes for oversight of commercial drug product manufacturing and distribution activities
  • Recent experience in working as a Responsible Person in accordance with European GDP guidelines is a plus
  • Experience in hosting and following-up of authority inspections including pre-approval inspections
  • Sound knowledge in 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 skills
  • Fluent in German and English
  • Ability to travel

Wir bieten Ihnen:

  • Kreatives Arbeiten in X-functional Teams
  • Offene und wertschätzende Unternehmenskultur
  • Multikulturelles Umfeld
  • Arbeiten in einem attraktiven, hochwertig ausgestatteten Gebäude mit Betriebsrestaurant
  • Kostenfreie Sportangebote und Sprachkurse
Über Ihr Interesse und auf Ihre aussage­kräftigen Unter­lagen freuen wir uns! Bitte be­wer­ben Sie sich direkt über unser Karriere­portal www.morphosys.de/karriere. Wir bieten Ihnen nicht nur aus­ge­zeichnete Ent­wicklungs­möglich­keiten, sondern unter­stützen Sie von Anfang an – auch bei Ihrem Umzug.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg