IT Manager for successful biotech in Odense M, Denmark

Would you like to be responsible for IT management and validation in an international company to help biopharmaceutical companies develop tomorrow's medicine?

Do you thrive in a job where you design, implement, and oversee the complex task of developing IT solutions that support our company's GMP activities in close collaboration with a team of helpful and skilled colleagues and external partners?

At Alphalyse, we use our innovative analytical methods and expert advice to assist biopharmaceutical companies across Europe and the USA in developing superior medicines. Over the past 20 years, we have built a brand as the industry expert and are experiencing rapid growth through innovation and a service-minded attitude.

Job description

As our IT Manager, you will be responsible for planning and defining our IT strategies. The position focuses on managing the analytical laboratory's IT infrastructure and digital systems. You will coordinate directly with the laboratory's Quality Control (QC) and Quality Assurance (QA) departments, external partners, and IT system suppliers.

You must develop and implement IT strategies and procedures in an EU-GMP Annex 11 and FDA 21 CFR Part 11 regulated environment in alignment with our overall business goals and objectives.

The main objectives are:

• Ensure timely delivery of IT projects - within budget and to the required regulatory standards.
• Define company-wide IT policies.
• Identify and manage potential technology risks and implement contingency plans to minimize downtime and protect our data.

We offer a unique opportunity to develop your competencies, support for acquisition of new skills as necessary, and a high degree of flexibility, including the possibility of working partly from home/remotely.

Your skills and experience

The position requires good skills in management and communication with stakeholders, as well as a systematic approach to documentation, writing procedures, and defining requirements. You will be expected to meet most of these requirements:

• Your background is a BSc/ MSc in life science, computer science, or similar.
• You have experience from a similar position or a background in pharmaceutical, healthcare, medical device, or hospital-related industries.
• You have knowledge and experience with GAMP5, FDA 21 CFR part 11, and EU GMP Annex 11.
• You hold a general understanding of Data Integrity concepts.
• You can read, write, and speak fluently in English & Danish.

You have a friendly attitude with good collaboration and English communication skills. You work systematically on multiple projects concurrently and thrive on new challenges. Proactive, service-minded, and team player are words describing your personality.

Are you interested in learning more about this job opportunity?

Please send your application as soon as possible and no later than August 27th, 2023, to Thomas Kofoed kofoed@alphalyse.com. Include a personal letter of motivation, your CV, and relevant diplomas. Name 1-2 contact persons for reference. For more information about the position, contact Thomas at +45 6310 6500.

About Alphalyse

Alphalyse is a Danish contract research laboratory founded in 2002. We use our passion for protein analysis to help clients develop safe and effective medicines. An innovative and service-minded approach has made us world leaders in reproducible quantitative mass spectrometry analyses – making data easy to understand and use and building strong client relationships.

Our team of highly skilled employees is our most important asset. We encourage a healthy work environment where you feel part of the team, are inspired to improve and innovate, and have room to use and develop skills. Learn more at www.alphalyse.com