GCP Quality Assurance Key Expert

Application deadline: 17-NOV-2024 
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2615 

Are you an experienced Good Clinical Practice (GCP) professional with a passion for ensuring compliance and optimizing quality management systems? Do you thrive in a dynamic environment where your expertise can significantly influence processes and drive quality standards? At LEO Pharma, we are dedicated to helping people achieve healthy skin through groundbreaking treatments. We invite you to join our Audit & GD Quality team, where you will play a crucial role in supporting our compliance within GCP and developing our Quality Management System.

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 Audit & GD Quality 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 GCP QA Key Expert, you will support the company’s compliance within GCP and maintain, optimize, and develop the Quality Management System. Your key responsibilities will include:

•    Supporting compliance with external regulatory requirements and ensuring quality standards comparable with industry standards.
•    Contributing to the assessment and communication of impacts on LEO processes, systems, trials, and data.
•    Participating as a host on GCP sponsor inspections, including support for preparations and follow-up.
•    Approving QMS documentation (e.g., Deviations, CAPAs, SOPs).
•    Providing quality expertise and advice to stakeholders on complex GCP-related matters.
•    Coaching on GCP compliance questions internally within Global Quality and LEO Pharma worldwide.
•    Contributing to Corporate and Global Quality’s goals and focus areas, including the development, maintenance, and optimization of quality processes.
•    Training stakeholders in GCP compliance.

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

•    A relevant degree within life science.
•    Minimum 8 years of experience in life science, with strong GCP experience and thorough knowledge of clinical trials.
•    Familiarity with quality regulations within GCP and a broad understanding of the entire clinical development process.
•    Excellent written and oral communication skills.
•    Experience in quality assurance, audit, and/or clinical experience.
•    Proficiency in English, both written and spoken
•    Ability to make good and timely decisions that keep the organization moving forward.

Your New Team

You will join a dedicated group of professionals committed to ensuring our quality processes are efficient, compliant, and effective. Reporting to the Senior Manager, you will collaborate closely with various internal departments. 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.