At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer.
Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.
Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
The jobholder should closely work with the Head of QA Compliance & Quality Systems, members of the Global Quality department and other relevant departments to further implement, manage, and continuously improve MorphoSys Quality Management System related to Computer System Validation. The job holder is one of the driving forces to enable that
the company is in a state of compliance with applicable
regulations and guidelines related to Computer System Validation.
- Management of the team QA-IT
- Management, support, and continuous
- improvement of the efficacy of MorphoSys QMS related to Computer System Validation and Data Integrity
- QA oversight of external vendors concerning CSV-related activities
- Representing QA-IT within MorphoSys to
- other relevant departments groups.
- QA-IT interface management with vendors and business partners
- Creation of global and local process descriptions related to Computer System Validation.
- Review and approval of process descriptions
- Supervision of validation activities and approval of the validation documentation of any GxP related Computerized System
- Continuous improvement of Q-processes and further development of the eQMS
- Centralized planning of CSV trainings
- Conduct and follow-up of IT audits and CSV-related self-inspections (internal audits)
- Support preparation, conduct and follow-up of authority inspections and customer audits in cooperation with the respective GxP teams
- Representing QA-IT in Quality Circles and Project Team Meetings (if applicable)
- Primary QA contact for collaboration partners concerning QA-IT related topics.
- Provide GxP compliant advice and guidance to CSV related requests
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