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Validation Lead

Medical
Frankfurt


As a NNIT CSV Subject Matter Expert you will be responsible for working closely with major NNIT clients to lead and drive some of the largest and most complex business critical IT projects in the Life Sciences industry. You will use your expert kledge to advise our clients during implementation, and your vast experiences to fulfill the client’s expectations. You will manage key stakeholder, follow-up on project milestones, and ensure reporting on the validation activities in collaboration with the Project Manager and Executive Sponsor.
Your focus will be solely on our major Life Sciences customers and key projects in Europe and US. You will bring your excellent consultancy mindset, communication skills, and vast project experience into play to identify the required solutions, that meet the client’s expectations. You establish yourself as a thought leader and trusted advisor and can challenge and advise the clients to reach the optimal solutions. It is important that you can adapt yourself to each client's needs and practices, as those can be very different.

Your responsibilities

Project delivery, including:

  • Participating in large and complex Life Sciences IT-projects as CSV Subject Matter Expert ensuring that full compliance and documentation requirements are met
  • Independently orchestrating and managing validation projects
  • Preparing and reviewing project validation documentation
  • Proactively identifying and implementing process and project improvements


Business development, including:

  • Continuously contributing to driving our Business Development activities and adjusting our services, products, and NNIT Winning Solutions
  • As part of the senior team, providing input to the global department strategy, goals and targets for our Compliance and Validation Consultancy services

Your qualifications

You must have:

  • 10+ years of working in a Quality role in Life Sciences biotech / pharmaceutical
  • 10+ years of working in Project Manager/Lead role within Life Sciences
  • Kledge of and experience with traditional and agile project management tools and frameworks
  • Kledge of and experience with IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11, Data Integrity etc.
  • The ability to communicate in English or German on expert level both orally and in writing (Danish language skills are not mandatory but could be an asset)
  • Excellent communication skills and experience with C-Level communication
  • Excellent stakeholder management skills both internal and external
  • A strong consultancy mindset that enables you to advise, challenge and consult clients


You should also have:

  • The ability to work in a challenging environment where client’s stakeholders need to be consulted, advised and led
  • Experience with Quality Management/Assurance of IT systems and/or infrastructure from previous work in the Life Sciences industry
  • Profound kledge of all phases of the classic V-model to apply current best practices
  • Kledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment
  • Strong computer skills including Word, Excel, PowerPoint, Project Management tools, Agile tools (DevOps, Jira etc.)
  • Experience with the Veeva Vault suit both in usage and implementation
  • Experience with working in an agile and semi-agile setup in a system validation context
  • Ability to work in a very dynamic environment with a sense of urgency
  • Excellent organizational skills and attention to detail and accuracy
  • Be able to travel in Europe to be onsite at our clients


Please apply with your CV in English.