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IT Validation Lead
1 week ago
At Novo Nordisk, we have a passion for improving patients' lives all over the world and right now we are looking for an IT Validation Lead to join us.
If you want to be part of a growing and engaging team and develop your skills within validation of data migrations to Quality IT systems, then this job could be something for you to consider. Don't stop here and become the newest member of the Integrated Quality IT department which has a strong focus on GxP data architecture and compliance within the Quality area at Novo Nordisk.
What's in it for you?
You will work closely with the data migration teams, selected migration partner, and other Digital Data & IT (DD&IT) teams. Your work as our IT Validation Lead will be related to the planning and execution of migration activities ensuring all requirements are fulfilled. In addition, you are to cover data migration process definition and optimization.
You are responsible for:
- End-to-end validation and qualification activities, including making a validation plan, validation report, design review, test strategy and execution etc.
- Performing various assessments such as Supplier assessment, IT risk assessment, IT requirements risk assessment, functional and data integrity assessments.
- Ensuring validated state of the system by performing periodic reviews, addressing deviations, creating and maintaining system documentation and instructions in cooperation with System Managers and IT responsible when needed.
- Ensuring that systems are in compliance with relevant internal and external regulatory requirements.
- Audits and inspections including implementing solutions to compliance gaps identified in audits and inspections.
Candidate profile
To be our new colleague as IT Validation Lead, we expect you can tick off most of the following boxes:
- Previous experience with GxP data in the pharma industry.
- Ability to understand and interpret technical documents and specifications, understanding of relevant regulations, standards, and guidelines.
- Experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments.
- Ability to understand and identify compliance gaps in a migration process.
- Ability to map and execute all deliverables to succeed with the project plan.
Overall, as our IT Validation Lead, you need to be able to combine compliance expertise, validation methodology, project management skills, communication skills, and problem-solving skills. You should be able to ensure that we are compliant with relevant regulations and standards, and that validation activities are performed in a consistent and compliant manner. You should also be able to work collaboratively with others to identify and solve compliance and validation issues.
Department overview
The department you are going to join is part of Novo Nordisk DD&IT and is specialized in data architecture and compliance for the Quality systems. We share and co-create knowledge and best practices around GxP Data Architecture, Validation, and Compliance and further collaborate closely on the same with colleagues from IT Quality Assurance, Global Data, and Integration Management Office.
Founded in Denmark in 1923, Novo Nordisk has become one of the world's leading healthcare companies. At Novo Nordisk, we are committed to driving change to defeat diabetes and other serious chronic diseases. To fulfill this purpose, we pioneer scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure disease.
With us, your skills, commitment, and ambition help us change patients' lives worldwide. In exchange, we offer you a rewarding and purpose-driven culture with talented and diverse co-workers. Therefore, your professional and personal development is essential for us, and in Novo Nordisk, the sky is the limit for career opportunities.
Any questions?
If you want to know more, please get in touch with our Department Manager, Integrated Quality – Tech & Data IT, Liviu Lupu at:
Deadline
20 March 2025
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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