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Job Summary
About Us Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
The Role Genmab is in the process of expanding our pipeline with more drug candidates and at the same time preparing to launch our own products. To support all the activities Genmab is looking to expand with a new IT QA Manager.
As IT QA Manager, you will establish and maintain the “Genmab Standard” for the validation of systems, migrations and updates, and will be supporting several IT validation projects.
You will be part of a global QA team and report to the Head of QA.
Key Accountabilities The responsibilities of the IT QA Manager will include, but not be limited to:
- 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
Skills & Experience
- You have a Master’s Degree preferably in Natural Science combined with an IT education.
- 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 have excellent English communication skills, both written and spoken, and you are an advanced user of MS Office and Sharepoint
Moreover, you can relate to following:
- As a person, you are competent within maintaining a comprehensive view
- Thrive and comfortable in a dynamic environment in which priorities and drives can quickly change.
- Ability to communicate clearly, are quality driven, and robust.
- You can work independently and have great interest in IT
Other Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful applicant a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
To learn more about Genmab, you can visit our website: http://www.Genmab.com/
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 23.12.2019, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
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