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IT Validation Lead

2 months ago

Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking an experienced IT Validation Lead to join our team at Novo Nordisk A/S. As an IT Validation Lead, you will play a key role in ensuring the integrity of our IT systems through rigorous validation processes.

Key Responsibilities

  • Develop and execute validation and qualification strategies for GxP and non-GxP Computerized Systems.
  • Conduct assessments, including supplier, IT risk, and functional and data integrity assessments.
  • Maintain system validation through regular reviews, deviation handling, and collaboration with System Managers and IT personnel.
  • Ensure systems comply with relevant internal and external regulatory requirements.
  • Foster strong relationships with colleagues and stakeholders through effective communication.

Requirements

  • Bachelor's degree in Engineering, Chemistry, Pharmacy, IT, or a related field.
  • Extensive experience in Computer System Validation (CSV) or manufacturing/production experience with recognized GMP certificate/qualification.
  • Strong knowledge of IT GxP validation, preferably in a regulated industry such as pharma or healthcare.
  • Relevant certifications, such as GAMP5, CSQE, CVP, CQA, CQE, CRMA, CISA, or CRISC.
  • Excellent communication skills and the ability to effectively communicate with stakeholders, team members, and management.

About Us

Novo Nordisk A/S is a global healthcare company headquartered in Denmark. We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in.

What We Offer

  • A rewarding and purpose-driven culture where your professional and personal development is highly valued.
  • A global community of 3000+ colleagues, driving digital, data, and IT.
  • The opportunity to work on complex projects and contribute to the development of innovative solutions.

How to Apply

For further information, please contact Agile People Leader Milda Bagdonaite.