System Compliance Manager, R&D Business Systems Management

1 month ago

Copenhagen, Denmark Genmab Full time

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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 a new system compliance manager for our enterprise electronic document management system (EDMS) – GenDocs, covering the clinical, regulatory, CMC and Quality Assurance areas in R&D. GenDocs is a global IT system based on the Veeva Vault cloud platform and it supports our dynamic and expanding R&D organization in Genmab.

R&D Business Systems Management is a global IT application team located in US and in Denmark which supports, develops, and innovates IT systems, primarily Veeva Vaults, and processes in R&D. We do this by working closely together with the line of business departments, understanding, and bridging their business needs to the system.

As a system compliance manager in our team, you will be improving and developing the IT compliance of the GenDocs system and the associated processes.

This will be done in close collaboration with the rest of the team by updating system related documentation, conducting periodic reviews, improving processes for operating and maintaining the system, participating in new Veeva projects as Validation Lead/SME, preparing and coordinating for audits and inspections of the GenDocs system, etc.

A part of the role will also be dedicated to system management work, for example implementation and validation of new system features, to ensure knowledge and experience of the system is continuously maintained.

This is a great opportunity for you to work and develop your competences within an IT system team and get first-hand experience of how a biotech company operates.The position also involves communication with external vendors, and with end users in line of business through projects, network groups, daily tasks etc.

Responsibilities

  • Maintain the system compliance documentation during operation of GenDocs (Validation Master Plan, Risk Register, system operation SOP´s, etc.)
  • Lead and conduct periodic review and other periodic compliance activities (critical user reviews, audit trail reviews, etc.)
  • Have oversight of vendor compliance documents (review compliance reports from Veeva)
  • Liaise with Genmab QA to ensure implementation of new system compliance requirements
  • Contribute to the optimization and development of system processes for the operation and maintenance of the GenDocs system
  • Participate in future Veeva Vault projects as Validation Lead/SME (author validation project documents, manage and coordinate test activities, etc.)
  • Help develop and optimize IT validation procedures and tools in the team and in Genmab
  • Participate in change- or issue-related system administration work in the team
  • Prepare, coordinate, and participate during audits and inspections of the GenDocs system

Requirements

  • We expect that you have a bachelor’s degree e.g. Life Science, IT, Engineering or similar
  • You have at least 5 years of experience from the pharmaceutical or biotech industry and +2 years from a similar role
  • 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 or Validation Lead
  • You have practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification
  • You have excellent communication skills in both Danish and 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

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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