IT Quality Assurance Key Expert

Application deadline:  
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2654 

Are you an experienced quality professional with a passion for ensuring compliance and driving improvements within GxP IT systems? Do you thrive in a dynamic environment where your expertise can significantly influence processes and relationships? At LEO Pharma, we are dedicated to helping people achieve healthy skin through groundbreaking treatments. We invite you to join our Corporate Quality team in Gdańsk, Poland, where you will play a crucial role in supporting and enhancing our IT quality processes.

Shape the LEO Pharma of tomorrow  

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities!

Your Role:
As an IT Quality Assurance Key Expert, you will independently perform quality support for complex tasks, drive projects with wide impact, and participate in highly complex projects. Your key responsibilities will include:

•    Participation in highly complex IT projects.
•    Approval of GxP documentation related to computerized systems. E.g. Change Control, Deviations, CAPA, Validation Plans, etc.
•    Act as a key IT QA expert regarding IT quality issues occurring in operation or as part of projects.
•    Providing GxP support and partnering with LEO stakeholders to establish and improve procedures.
•    Conducting GxP training and quality risk management activities.
•    Overseeing the IT QMS, performing compliance gap analysis, and approving GxP records.
•    Participating in authority inspections and audits.
•    Acting as an internal/external IT auditor within GxP IT Systems.

Your Qualifications
To excel in this role, you will need:

•    A Master’s degree or similar in Computer or Natural Science.
•    Minimum 10 years of experience within a GxP area and regulated IT activities, with expertise in compliance with 21 CFR Part 11, Annex 11, GAMP 5, ISO 13485, Data Integrity, ISO 9001, ISO 27001 (Information Security) & ISO 22300 (Security and Resilience) and IT activities such as applications, infrastructure, security, databases, and serialization.
•    Profound knowledge of regulated IT activities and the pharmaceutical industry (within GMP, GVP, GCP).
•    Fundamental knowledge in several pharmaceutical disciplines and quality regulations and systems company-wide.
•    Comprehensive experience from the pharmaceutical industry and the ability to influence quality decisions taken by internal and external stakeholders.
•    Proficiency in English, both written and spoken
•    Ability to handle complex issues and making decisions with a global perspective.

Your New Team

Welcome to the Corporate Quality at LEO Pharma! Here, you will join a dedicated group of professionals committed to ensuring our quality processes are efficient, compliant, and effective. Reporting to the Senior Director, you will collaborate closely with various internal departments and external partners. Our team values open communication, collaboration, and a shared commitment to excellence, continually pushing the boundaries to deliver innovative quality solutions.

Contact and Application

Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application!
At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.
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. 

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
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 difference.
 
For certain positions, LEO Pharma might complete a background check conducted by a third party.