IT Compliance Expert

Location: Gdansk 80-309, Poland, Poland 
Contract type: Permanent 
Job ID: 3306 

IT Compliance Expert

Application Management, R&D, Quality & Commercial we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals

Join us in creating a future legacy in medical dermatology

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years’ experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines. 

Your role

You will oversee vendor IT systems in clinical trials by managing global processes, ensuring regulatory compliance, and adhering to periodic system review protocols. 

• Maintain an updated overview and inventory of all IT systems used in LEO Pharma clinical trials, including compliance documentation and vendor IT system details.
• Drive vendor IT system risk assessments during selection, oversee qualification and compliance activities, and support new technologies in collaboration with IT-QA.
• Develop, maintain, and train key functions on processes and procedures for vendor IT system oversight, ensuring alignment with regulatory requirements.
• Establish and periodically review Supplier Quality Plans, coordinate vendor IT system documentation, and support inspections, audits, and CAPA follow-ups.
• Act as the single point of contact for vendor IT systems, facilitating collaboration between trial teams and vendors on system qualification, periodic reviews, and compliance.
• Participate in vendor governance meetings, internal audits, and inspections, supporting trial teams and ensuring vendor IT system compliance.

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:

• MSc in Natural Sciences, Information Technology, or a related field.
• 4-6 years of experience in quality, data, or IT systems within the pharmaceutical industry.
• Demonstrated expertise in computer system validation with a strong understanding of GAMP5.
• In-depth knowledge of clinical development processes and ICH GCP guidelines.
• Self-motivated, proactive, and action-oriented with a strong quality mindset.
• Solution-focused, highly organized, and structured with excellent communication skills.
• Fluent in written and spoken English.

Are you a our new IT Compliance Expert with a passion for IT Systems? At LEO Pharma, we are committed to helping people achieve healthy skin through pioneering treatments. We invite you to join our IT Department in Gdańsk, Poland, and be a key player in Compliance Team.

Your new team

You'll be joining a a dynamic and forward-thinking group of professionals dedicated to ensuring excellence in clinical trial IT systems and compliance. Our team values collaboration, innovation, and a proactive approach to overcoming challenges. Together, we drive impactful solutions, streamline processes, and set high standards in vendor IT system oversight. In this role, you’ll play a key part in fostering teamwork, enhancing compliance, and supporting transformative projects that advance clinical development. 

Your application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. Please refrain from adding a photo to your CV.

Beyond the skin

Become part of LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. We are are the legacy-builders of the future – enabling people to have a better today and tomorrow. With the world as our lab, we are transforming innovative ideas into more effective and easier-to-use medicines. Through collaboration and partnerships, we can do much more.  

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a fundamental difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us and make an impact in, on and far beyond the skin. Apply now!