Validation Lead

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Ballerup

In Novo Nordisk, we have a passion for improving patients’ lives all over the world. Will you help us bringing that passion to life? Would you like to further develop your expertise within validation and quality control? We are looking for a skilled Validation Lead to help drive the digital transformation of Novo Nordisk. Apply now to become part of the LABS (Laboratory Solutions) department! The Position As a validation lead you will be responsible for defining the validation strategy, validation planning and reporting in relation to a specific implementation or upgrade of an IT system with GxP (healthcare) impact. You will work closely with the product owners, Line of Business (LoB) and other stakeholders to understand the scope of validation and act as liaison with LoB QA and ITQA. This is a job for those who are excited to work with technologies, validation, testing and quality control in agile IT projects. Your key tasks will include:
  • Participating in large scale IT projects as the validation expert thus responsible for execution of validation and quality control activities
  • Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, and reporting and ensuring that these are executed effectively.
  • Helping to develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing.
  • Being responsible for performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.
  • Ensuring the validated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers and IT responsible when needed and that systems are following relevant internal and external regulatory requirements.
    • Another key task will be to execute audits and inspections including finding solutions to compliance gaps identified during the procedure. You will also help the development teams to develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans. Qualifications To be successful in this role, you will need the following requirements:
  • Completed a bachelor’s or master’s degree within Computer Science, Engineering, Software Development or other related fields.
  • GxP compliance experience.
  • 5-10 years of extensive experience within IT Validation from the pharma industry or other regulated industries.
  • Experienced in working with large scale projects and validation, preferably working in an agile manner.
  • Quality mindset with good ability to execute within deadlines is essential.
  • Stakeholder management, facilitation and communication skills.
    • You are proactive and thrive in a challenging, dynamic, and ever- changing environment. You can handle several tasks at a time and keep an ongoing focus on results. Being open minded and positive and have the ability and feel confident to collaborate with external parties, customers, vendors, and consultants. In addition, you must have strong work ethic and willingness to take responsibility and drive success. About the Department LABS is a part Digital Data & IT Product Supply organisation which has employees based in Denmark, India, US, China, France and Brazil. The strategic objective of the unit is to be the IT partner for the business, ensuring that we provide the IT solutions and support to the Novo Nordisk production solution as well as supply chain needs worldwide. In LABS you will be part of a highly engaged department developing and improving IT systems which are core to the laboratory processes in Novo Nordisk. Though you will be working with a lot of colleagues from around the globe, the job location will be in Ballerup (Denmark). Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Lilian Juma Lausen +45 3079 1849. Deadline 15 March 2024. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Arbejdsstedet er beliggende i Ballerup.

    Jobbet er oprettet på vores service den 15.2.2024, men kan have været deaktiveret og genaktiveret igen.

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