IT Quality Systems Lead

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About Us
At Genmab, we're committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

Role Overview
The successful candidate will be responsible for implementing new IT functions and features in our enterprise electronic document management system (EDMS), GenDocs, covering clinical development, regulatory affairs, CMC, and QA areas in R&D. This includes leading and contributing to the optimization and innovation of the GenDocs system and its related processes.

Responsibilities
• Configure, implement, and validate new system features and functions
• Participate in the resolution of daily issues and incidents from users of the systems
• Continuously improve procedures, work instructions, templates, and other tools to optimize the systems and related processes
• Maintain the system documentation during the operation of the systems

Requirements
To succeed in this role, you must have a bachelor's degree in Life Science, IT, Engineering, or a similar area. You should also have at least 5 years of work experience from the pharmaceutical or biotech industry, with 1-2 years' experience from a similar role. Practical work experience with EDMS systems, preferably Veeva Vault administrator and platform certification, is required. In addition, you should have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management. Experience participating in IT GxP projects, either as project SME, Functional Lead, or Project Manager, is also necessary.

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