Job Opportunities in Poland
October 15, 2024
LEO Pharma A/S
Gdańsk
OTHER
QMS Process Expert
Field of work: Quality
Posting Date: 10 Oct 2024
Application deadline: 12-Nov-2024
Location: Gdańsk 80-309, , Poland
Contract type: Permanent
Job ID: 2602
Location: Gdańsk 80-309, , Poland
Contract type: Permanent
Job ID: 2602
Are you passionate about driving strategic direction and continuous improvement initiatives within Quality Management Systems? LEO Pharma is looking for an experienced QMS Process professional 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 Expert, you will be responsible for ensuring that global processes are compliant with regulations and internal and external standards. You will act as a Process Owner Delegate (POD) for the Customer Complaint process (C-COMP), Post Market Surveillance (PMS), and Product Quality Review (PQR). In this role, you will:
- Support global compliance, maintenance, and development of the LEO Pharma Quality Management System.
- Manage assignments within Gx P processes to ensure value-adding and efficient operations.
- Collaborate with Subject Matter Experts (SMEs) to develop and maintain process maps and performance measures.
- Execute tasks defined for each of the processes and operationally drive the periodic tasks within C-COMP and PMS processes.
- Develop and maintain strategies for the processes in scope, ensuring continual improvements, compliance, and strategic fit.
- Lead process groups across GLT areas, ensuring adequate competences and resources for managing global quality processes.
- Perform stakeholder and relationship management with VPs, Directors, Site Leads, Senior Managers, SMEs, and internal and external collaborators.
- Drive quality initiatives/projects and implement new systems and the LEO Pharma QMS.
- Act as SME and support larger projects with knowledge on LEO QMS.
- Work in My Doc, My QMS, and other relevant quality systems.
- Present relevant topics and processes during audits and authority inspections.
- Support annual Gx P training for Global Quality.
Your Qualifications
We are looking for a highly qualified professional with:
We are looking for a highly qualified professional with:
- A Master of Science in pharmacy, engineering, or equivalent education with a focus on Quality systems and processes.
- In-depth knowledge of customer complaint processes within the Medical Device or Pharmaceutical industry.
- In-depth knowledge of one or more of the following QMS processes: PMS, PQR, CAPA/DEV.
- Experience with leading projects and initiatives in a global matrix organization across cultures and time zones.
- 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.
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
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.
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.
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