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IT Quality Specialist

IT Quality Specialist to support the clinical projects

Are you passionate about good IT practices and digitalisation? Do you enjoy helping people ensure IT quality the most efficient way? Is your personality friendly, open-minded and robust? We seek an engaged and dedicated specialist with a deep knowledge of IT processes to drive IT quality and optimisation activities together with great colleagues and stakeholders across Novo Nordisk.

About the department

The R&D Quality area is part of Development, have a dotted line to NN Quality and is responsible for quality assurance and compliance support in pharmaceutical Research & Development. R&D Quality is divided into seven departments. The open position is in the Global Clinical Processes & IT department responsible for deviations, GCP serious breaches, digitalisation initiatives, vendor assessments, Quality Assurance for device and SaMD trials, and Quality Assurance for IT systems.

The position

The IT quality assurance and support activities are growing and therefore we need an extra resource in our department.

As IT Quality Specialist you will be responsible for ensuring IT compliance and quality oversight in Development and support the digital transformation.

Together with your IT quality colleagues, you will support the clinical areas in software development and implementing digital initiatives. You will provide QA support for IT systems, ensure inspection readiness, support GCP vendor assessments with IT focus and participate in GCP IT supplier audits. There will be participation in IT projects, involving cooperation with stakeholders and global service providers where you ensure IT quality aspects.

It is expected that you actively drive collaboration across areas in Novo Nordisk to ensure and alignment and knowledge sharing. You will ensure compliance with regulatory requirements and will continuously improve the quality mind-set within Novo Nordisk whilst still ensuring we have competitive speed and flexibility to meet our business needs. You strive for simplicity and demonstrate a risk-based, solution-oriented approach.

Qualifications and competencies

You hold a relevant scientific academic degree, e.g. within Computer Science, Software Engineering or equivalent and are fluent in written and spoken English. The position requires significant insight into software development and good IT practices, e.g. requirements gathering, change management, configuration management, risk assessment, testing and release. You have worked extensively with regulated IT systems regarding validation and compliance and have 6+ years of working experience in these areas. You have knowledge and great interest within digitalisation, new technologies and work methods.

You are a team player prepared to work in a dynamic international environment with tight deadlines while maintaining a good sense of humour. You have a pragmatic and diplomatic approach to stakeholder resistance and have strong interpersonal skills. You are highly engaged, robust in meeting challenges and willing to take responsibility. You are innovative and proactive and enjoy driving improvement of systems and processes. The job requires strong strategic focus, high degree of independence and great leadership competencies.

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