System Compliance Manager, Digital Systems Management, Veeva Vaults

1 maand geleden

Utrecht, Nederland Genmab Voltijd

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 an additional System Compliance Manager for 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.

Digital Systems Management is a global IT application team located in US and in Europe 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 optimized systems.

As a System Compliance Manager in Digital Systems Management, you will be improving and developing the IT compliance of the GenDocs system and the associated business and administration processes around the system.

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

A part of the role will also be dedicated to system management work, for example configuring, implementing, and validating new system features, to ensure your knowledge and skills of the system are continuously maintained.

This is a great opportunity for you to work and develop your competences and skills 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, annual system review etc.)
  • Have oversight of vendor compliance documents (review compliance reports from vendors)
  • Liaise with QA, Legal, IT and other Genmab departments to ensure implementation of compliance requirements impacting the systems, for example within CSV/CSA
  • Develop and optimize system processes for the operation and maintenance of the GenDocs system
  • Participate in future Veeva Vault projects as Validation Lead/SME (write validation project documents, manage, and coordinate test activities, etc.)
  • Develop and optimize IT validation procedures and tools in the team
  • Participate in system configuration 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. 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 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 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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