System Manager, Digital Systems Management, Veeva Quality

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.

The role
Genmab is looking for an additional System Manager to help us maintain, develop, and operate our enterprise electronic document management system (EDMS), GenDocs, covering the clinical development, regulatory affairs, CMC, and QA areas in R&D.

GenDocs is a global IT system in Genmab based on the Veeva Vault cloud platform and it supports daily operations in our dynamic and expanding R&D organization.

As a System Manager in Digital Systems Management, you will implement new IT functions and features in the systems to improve and optimize the business processes, especially in the quality systems domain, like Veeva QualityDocs, QMS and Training.

This will be done in close collaboration with the rest of the team, the line of business departments, and the vendors of the systems. You will act as a functional lead where you participate and contribute to the configuration and development of the systems.

An important part of the role is to be in near contact with line of business departments to handle their requests, questions, or need for help. This requires a good combination of IT system knowledge, business process understanding, and experience with GxP, system configuration, and validation.

Responsibilities

• Lead and contribute to the optimization and innovation of the GenDocs system (Veeva Vaults), and their related processes in line of business
• Participate in the daily system management work, for example configure, implement and validate new system features and functions
• Participate in the resolution of daily issues and incidents from users of the systems
• Continue to improve procedures, work instructions, templates, and other tools to optimize the systems and related processes for operating and maintaining the systems
• Participate in future Veeva Vault projects as Functional Lead, SME or as Project Manager
• Maintain the system documentation during the operation of the systems
• Liaise with line of business departments and IT Business Partners to align plans for new features and projects for the future development of the systems
• Prepare and contribute during audits and inspections of the systems

Requirements

• We expect that you have a bachelor's degree in Life Science, IT, Engineering or similar area
• You have at least 5 years of work experience from the pharmaceutical or biotech industry, and 1-2 years' experience from a similar role
• You have practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification
• It is an advantage if you have worked or collaborated with line of business areas, for example, QA, CMC, clinical development, to optimize their quality systems and processes
• You have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management
• You have participated in IT GxP projects, either as project SME, Functional Lead, or Project Manager
• You have excellent communication skills in English, written and oral
• It is an advantage but not a requirement if you have experience with IT test tools, like HP ALM, Jira, etc.

Moreover, you meet the following personal requirements:

• Ability to work independently as well as in teams
• Service minded and meeting challenges with a smile and a positive mindset
• Pragmatic attitude, able to balance, and see other people's perspective
• Take responsibility and have a personal drive
• Structured and systematic, and can adapt the level of right detail to the context

Locations
Genmab leverages the effectiveness of an agile working environment for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that connect employees while being immersed in our state-of-the-art laboratories.

About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.

Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.

Location: Copenhagen - Carl Jacobsens Vej 30

Additional location:

• Utrecht
• Princeton, NJ