IT QA Specialist / Senior Specialist

Are you an experienced IT QA Specialist looking to continue your career in an innovative industry? Do you want to make a significant impact on patients around the world? Are you passionate about quality assurance and problem-solving in a GXP environment? If you answered yes to any of these questions, then read on.

We are looking for experienced IT QA specialist, ideally with audit experience, to join our IT QA team and provide support to users and systems across Lundbeck. We are on a journey with global projects such as Veeva and MES, and we need dedicated professional to help us succeed.

Your new role

As an IT QA specialist, you will work across Lundbeck’s organization, managing a wide range of activities throughout GXP areas. Based on you profile and experience, you may be working with some of the major projects we are currently implementing, such as MES (PAS-X and Inmation), Veeva (currently Quality Docs & Vault Training, but projected to expand in scope), or Safety Surveillance for the pharmacovigilance area.

This is an exceptional opportunity to further develop your professional expertise, working closely with a variety of GXP systems and processes in Lundbeck.

You will collaborate with skilled and dedicated colleagues across the organization, contributing to the pharmaceutical value chain and making a positive impact on patients suffering from brain diseases.

As part of the job, you may be:

• Managing our internal and external audit program and perform audits on-site and remote.
• Ensuring that our methodology for risk-based computer validation is developed and maintained.
• Develop and implement validation strategies for specific IT systems, focusing on business processes and data integrity.
• Support major projects in testing, validation, definitions of strategies and maintenance procedures.
• Support, identify, describe, and mitigate potential data integrity risks related to the use of GXP IT systems.
• Writing validation documents and supporting users acting as Validation and Test Manager.
• Evaluate and approve validation documents / change requests for systems throughout the organization.
• Develop and maintain our internal QA procedures and processes.
• Support our Global IT organization with approval of deviations, change requests, training etc.

Your future team

You will be joining our well-established Corporate IT QA Department, currently consisting of 12 committed colleagues working with various aspects of IT compliance, testing, and quality throughout Lundbeck. Our team creates and implements procedures and tools to ensure the quality and compliance of IT systems used by our colleagues. By doing this, we contribute to ensuring product quality, patient security, and data integrity.

We plan and execute our work with respect for agreements and deadlines. You will be empowered to manage your own tasks, supported by a team culture where we assist each other and provide feedback to ensure everyone has growth opportunities. Your input and feedback will be highly valued.

What you bring to the team

• You have substantial experience in IT QA, with risk-based validation of major GXP computer systems.
• You have experience in managing and performing internal as well as external audit.
• You can manage and engage with colleagues at all levels of the organization.
• You have good communication and interpersonal skills.
• You have a relevant education (e.g., in IT, pharma, engineering, or science).
• You have the capacity to prioritize assignments and identify opportunities for improvement.
• You are self-motivated, structured, and responsible with respect to deadlines and quality.
• You can listen and adapt solutions to fit the situation.
• You are fluent in speaking, reading, and writing English.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion

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Apply now

Do you see yourself in this role, then we want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all our requirements? We still want to hear from you!

Upload your CV and include information about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Vice President, Quality Assurance, Anne Bekker-Jensen at ABEJ@lundbeck.com or 45 3083 5067.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

#LI-Hybrid

About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.