QMS Process Key Expert

Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2606 

Are you passionate about driving strategic direction and continuous improvement initiatives within Quality Management Systems? LEO Pharma is looking for an experienced QMS Process Key Expert to join our CQ Processes & Systems team in Gdansk, Poland. If you thrive in a dynamic and collaborative environment and are driven by excellence, this role is tailor-made for you!

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!
In CQ Processes & Systems team we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Your Role:
As a QMS Process Key Expert, you will be responsible for ensuring global processes are compliant with regulations and internal and external standards. You will also ensure these processes are value-adding, efficient, and well established within the lines of business. Your key responsibilities will include:

•    Acting as Process Owner Delegate for Document & Record Management, Business Process Management, Quality Risk Management, and Validation.
•    Supporting global compliance, maintenance, and development of the LEO Pharma Quality Management System.
•    Driving global projects to simplify, align, and optimize the LEO Pharma Quality Management System.
•    Leading initiatives to transform our QMS to be process-driven and driving the digitalization journey for GxP documentation (QDMS project).
•    Acting as expert advisor and Data Owner for systems supporting Document Lifecycle Management (e.g., Quality Vault).
•    Developing and maintaining a strategy and plan for the processes in scope to ensure continual improvements, compliance, and strategic fit.
•    Leading process groups across GLT areas to ensure adequate competences and resources for managing global quality processes.

Your Qualifications
We are looking for a highly qualified professional with:

•    A Master’s degree in natural science or equivalent education.
•     Over 10 years of experience in the field of Quality or Regulatory.
•    In-depth knowledge of pharmaceutical quality system requirements.
•    Experience in working with quality processes, facilitating meetings, and maneuvering among stakeholders.
•    Experience with IT systems supporting QMS (document and process management), document life-cycle management, record management, and archiving.
•    Experience with Data Integrity, Quality Risk Management, and Validation and Qualification processes.
•    Excellent communication skills, both orally and in writing, in English 
•    Being result-oriented, effective, pragmatic, and process-oriented.
•    Having a positive and proactive approach.
•    Being team-oriented and working collaboratively with all organizational stakeholders.

Your New Team
At LEO Pharma, we pride ourselves on our collaborative and supportive work environment. As part of the CQ Processes & Systems team, you will work closely with various internal departments, including MSAT, P&PT, Global Quality, Site Leads, process groups, VPs, Directors, Senior Managers. You will also engage with external stakeholders to ensure our systems and processes align with regulatory expectations and industry best practices.
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
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.

At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

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