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IT QA Manager

Genmab is in the process of expanding its clinical pipeline with more drug candidates, and at the same time, Genmab is preparing to launch its own products.

As IT QA Manager at Genmab you will be part of the QA team consisting of 12 Specialists and report to the Head of QA. Furthermore, you will have a wide collaboration across the organization with the overall goal to develop new and innovative medicines for patients.

Genmab is looking for an IT QA Manager, who will establish the “Genmab Standard” for the validation of systems, migrations and updates, and will be driving several IT validation projects.

Your main responsibilites are:

  • Ensuring compliance to applicable regulatory requirements of the computerized systems that is or will be implemented
  • Managing validation processes and validation activities performed in Genmab across the whole Development organization
  • Identifying and implementing improvements of the IT system life cycle and validation processes to ensure a pragmatic and risk based validation approach
  • Support IT in establishing and maintaining an IT infrastructure qualified for intended use i.e. in supporting validated systems.
  • Securing compliance with internal procedures and external GxP demands
  • Preparing computerized system risk and regulatory impact assessments and other evaluations
  • Coordinating validation activities in compliance with corporate policy, local procedures and regulatory expectations.
  • Reviewing and assisting in developing departmental standard operating procedures (SOPs) and validation programs
  • Supporting vendor qualification activities
  • Supporting infrastructure qualification/computerized system validation projects as allocated 

Your qualifications are minimum 5-10 years of IT QA Management experience within the Life Science industry. You have documented experience with implementing and validating IT systems, as well as supporting and maintaining existing IT systems keeping them in a validated state. You have experience with cloud based software, internal hosted systems and with qualification of IT infrastructure, e.g. as part of an ITIL program. You are competent within stakeholder management, have a good business understanding and have worked with GDPR principles.

You have excellent English communication skills, both written and spoken, and you are an advanced user of MS Office and Sharepoint. 

You have a Master’s Degree preferably in Natural Science combined with an IT education. 

As a person, you are competent within maintaining a comprehensive view and you are comfortable in a dynamic environment in which priorities and drives can quickly change. You are able to communicate clearly, are quality driven, and robust. You work independently and have a great interest in IT and new trends and tendencies within the area.

Genmab offers a challenging position within IT QA, where the right candidate will get the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients. Genmab is an organization with a short chain of command and as IT QA Manager, you will have the opportunity to influence your own work as well as your personal and professional development.

Travelling: 30 days per year

Domicile: Kalvebod Brygge, Copenhagen

For more details about the job or the company, please contact Senior Consultant Louise Nielsen, Unique Human Capital on M +45 29 74 24 24 or e-mail: lin@uhc.dk. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
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