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:

  • Leading and developing the QA team responsible for Good Clinical  and Good Pharmacovigilance Practice (GCP/GVP)
  • Reporting to VP, Head of Global QA & Internal Audit
  • Setting up yearly audit plan and leading the planning, performing and following-up of audits at CROs, PV service providers, external laboratories, clinical trial sites, and in house GCP / PV systems
  • Hosting of authority inspections
  • Providing strategic leadership to your team in implementing and tracking suitable Key Performance Indicators to measure effectiveness of GCP/GVP related Quality Systems
  • Driving initiatives for further improvement of the GCP/GVP Quality System
  • Ensuring that the GCP/GVP QA team delivers (audits, metrics, CAPAs) in a timely manner
  • Write / review Quality Assurance SOPs
  • Leading interactions with external CROs and PV services providers regarding QA counterpart
  • Responsible that GCP/GVP QA team acts as business partner towards relevant internal departments (e.g. Clinical Operations, Clinical Development, Drug Safety, Pharmacovigilance)
  • Providing advice to relevant departments to incorporate any process changes in relation to changes in legislation and keeping up with future changes in legislation
  • Managing and providing support, education and training to other departments involved in clinical trials, drug safety and pharmacovigilance activities
  • Providing input to VP, Head of Global QA & Internal Audit regarding budget and personnel planning

Your Requirements:

  • University Degree with a minimum of 12 years of professional experience in GCP and GVP Quality Assurance within pharmaceutical and / or biotech industry
  • Experience in hosting and following-up of authority inspections including pre-approval inspections from European authorities and FDA
  • At least 8 year experience in setting up and managing teams of QA professionals in the area of GCP and GVP
  • Excellent in depth knowledge in international regulations and guidelines (EU / FDA regulations, ICH-GCP etc.)
  • Deep subject matter expertise in GCP and GVP compliance as well as in conduct of international clinical trials
  • Deep knowledge and understanding of drug development process and the Global Regulatory Requirements
  • Strong communication skills both verbally and written
  • Team player with well-developed interpersonal abilities
  • Proven ability to proactively resolve issues/discrepancies in a flexible and constructive manner
  • 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