IT Validation Specialist, Group IT

Do you want to ensure that our IT organization continues to deliver solutions supporting GN in an efficient, compliant, and secure way? And do you want to develop yourself in a global, recognized conglomerate within hearing instruments, audio-, video-, and gaming equipment? Then you might be our new colleague.

As our IT Validation Specialist, your main role is ensuring that our IT systems and software applications meet the necessary external and internal regulatory and compliance standards from authorities, customers, and the organization. You will validate and verify that our systems are functioning correctly and efficiently, supporting our focus on quality and compliance.

The team you will be part of:
At our global HQ, located in Ballerup Denmark, you will be part our IT QA & Compliance team, part of our Global IT department with colleagues located across the globe. You will work in a global, collaborative, hybrid work work environment .

“This is where we ensure Group IT stays compliant and keeps delivering IT solutions of high quality by providing deep knowledge of IT system validation and regulatory compliance”, says Head of IT QA & Compliance, Line Rasmussen, who you report to.

Your contribution is appreciated:
Since you will work with simultaneous IT validation projects simultaneously, you maintain a clear overview, excel in thorough planning, and possess IT technical knowledge with the ability to make the complex understandable to your colleagues and stakeholders, across the organization.

In addition you will:

• Develop and ensure validation plans, protocols, and reports for IT systems and software applications, following the GAMP5 principles.
• Conduct risk assessments and impact analyses to identify validation requirement and continuously improve the quality and compliance of IT processes and documentation.
• Collaborate with cross-functional teams to ensure validation activities are aligned with project timelines and regulatory requirements.
• Perform testing and validation activities ensuring systems meet specified requirements.
• Assist IT process owners in creating and updating SOPs/procedures.
• Document and maintain validation records, ensuring accuracy and completeness.
• Provide guidance, training and support to stakeholders on validation processes and procedures.
• Stay up to date with industry standards, regulatory guidelines, and best practices related to IT validation.
• Participate in audits and inspections, providing validation documentation and support as needed.
• Tasks will be coordinated and aligned internally in the team based on skills, and preferences.

To succeed in the role, we’re looking for the following:

• A higher educational background within IT, Life Science, or related fields of studies.
• Relevant experience within IT Software validation according to GAMP5.
• Have knowledge of validation principles, methodologies, regulatory requirements, and quality assurance within the Life Science industry (e.g., FDA, GxP, ISO).
• Possess well-developed project-, and stakeholder management abilities.
• Capable of communicating fluently in English, where it will be beneficial if you are also fluent in Danish, although this is not a prerequisite for the position.
• Skilled at working in a group while being responsible for your contributions.
• Detail-oriented with a focus on quality and compliance.

At a personal level, you are forward-thinking, collaborative and motivated, with a focus on delivering high-quality work and can work with limited supervision in a significant global environment.

We encourage you to apply
Even if you don’t match all the above-mentioned skills, we will gladly receive your application if you think you have transferrable skills. We highly value a mindset, motivation, and energy, that aligns with our core values, to not only ensure success for you, but for your team and the wider GN organization as well.

We are dedicated to an inclusive recruitment process
All applicants will receive equal consideration for employment. As such, we encourage you to submit your CV without a photo to ensure an equal and fair application process.

Should you have any special requirements for the Interview please let the hiring manager know upon accepting invitation to interview.

How to apply?
Use the ‘APPLY’ link no later than 12th of January 2025. Due to the holiday seasons, applications are assessed on a continuous basis with the expectation of interviews will be conducted at the beginning of January.

On a time crunch? Feel free to only submit your up-to-date CV including a few sentences outlining your motivation for applying – quick and easy.

If you would like to know more about the position, please contact Head of IT QA & Compliance, Line Rasmussen on +45 2835 1496.

Join us in bringing people closer
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses and provide great experiences for audio and gaming enthusiast.

We hope you will join us on this journey and look forward to receiving your application.

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Location: Ballerup