Senior ITQA Compliance Manager

Job title:

Senior ITQA Compliance Manager

Company

ALK-Abelló

Job description

Are you passionate about ensuring IT compliance in highly regulated environments while working across multiple global departments?We are seeking a skilled and experienced Senior ITQA Compliance Manager to join Global Quality. The position focuses on ensuring compliance of IT Systems with linked processes and providing support to IT systems and projects globally in the functional areas Commercial Operations, Pharmacovigilance, Clinical Operations, Global Regulatory Affairs and Global Business IT.The positionAs the Senior IT QA Compliance Manager, you will support the areas with: * Operational tasks:

• Guidance and support to ensure compliance to IT specific regulatory compliance requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, other GxP areas.) and internal quality processes.
• Oversee and review quality documentation for IT systems and processes, such as GxP determinations, validation plans, validation reports, system lifecycle documentation, risk assessments and test documentation.
• Provide training in ALK Quality Management of Computerized Systems processes.
• QA approval of Change Controls, Deviations, CAPA and SOP/WIN.
• Provide ad hoc expertise to critical issues
• Project Participation:

• Actively participate in Global Quality (GQ) improvement initiatives to enhance efficiency and quality within IT systems with linked processes e.g., Quality Document Management and Veeva QualityDocs and Training and SAP.
• Provide IT QA expertise during the implementation of IT systems supporting the areas described above.
• Lead Auditor:

• Plan, execute, report and follow up on audits of suppliers of IT systems supporting Commercial Operations, Pharmacovigilance, Clinical development and Regulatory Affairs. This to assess compliance with regulatory requirements and quality standards.
• Plan, execute, report and follow up on internal audits of IT systems globally in ALK.
• Facilitate and provide support for external audits and inspections from authorities (e.g., FDA, DKMA), particularly for systems supporting the above-mentioned areas.

Your profileWe expect that:

• You hold an academic degree in Engineering, Pharmacy or Natural science. You have at least ten years of experience from the pharmaceutical or medical device industry and within GxP, and are experienced with areas such as cloud-based systems, outsourced IT services, automated testing etc.
• Have extensive experience with IT system and QA, demonstrating a strong understanding of quality management systems and tools.
• Have experience with audits as Lead Auditor or participation in audits and inspections as SME – this will certainly be an advantage.
• Experience with QA support to the above areas will also be an advantage.

Your personal characteristics:

• Possess high drive and you take initiative and proactive action.
• Ability to work independently, but also being a team player.
• Relation builder working respectfully across different cultures with flexibility.
• Solid cross-cultural communication skills who excel both verbally and written in English, Danish is an advantage.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.ApplyApply by attaching your CV and a short letter of motivation, no later than 8 September 2025.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don’t wait to apply! We reserve the right to take down the advert when we have found the right candidate.Do you want to learn more about our company, we encourage you to visit us at . For further information regarding the position please contact Siren Jenssen Østerberg, VP Global Quality R&D and Commercial Operations, + 4550899540.We are looking forward to hearing from you!Send applicationShare on:Region:

• Region Hovedstaden

Job type:PermanentWorking hours:Full-timeWorking days:DayIndustry sector:ResearchJob level:ManagerPosition type:ManagerApplication deadline:08/09/2025Location:Hørsholm, DenmarkCompany homepage:Office address:Bøge Allé 1 2970 HørsholmOffice location:ALK-Abelló A/SALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy.
ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.
We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.

Expected salary

Location

Hørsholm, Hovedstaden

Job date

Fri, 22 Aug 2025 22:18:43 GMT

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