External Manufacturing Quality Support Lead

Application deadline:  
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 3692 

Are you ready to make an impact in pharmaceutical quality assurance? LEO Pharma is seeking a dedicated and proactive External Manufacturing Quality Support Lead to join our Quality Support team. In this exciting role, you’ll collaborate across functions and external partners to ensure the highest quality standards in external manufacturing processes. If you thrive on problem-solving, driving continuous improvement, and working in a dynamic environment, we want to hear from you!  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 medicine.

Your Role: 

As an External Manufacturing Quality Support Lead, you will play a key role in ensuring compliance with LEO Pharma’s QMS and cGxP requirements. 
Your responsibilities will include:  

•    Guiding and supporting external manufacturing operations to meet LEO QMS and cGxP requirements.  
•    Initiating, supporting, and driving quality records, including deviations, CAPAs, supplier complaints, change controls, and customer complaints in collaboration with External Manufacturing Leads.  
•    Ensuring the right prioritization of CMO-related quality records in cooperation with the Head of Quality Support, QPs, External Manufacturing and other stakeholders.  
•    Supporting new product and CMO onboarding projects, including managing associated QMS records.  
•    Providing process updates, advice, and coordination to ensure quality issues are resolved timely and effectively.  
•    Supporting the compilation and reporting of performance metrics and ensuring inspection readiness at all times.

Your Qualifications

To succeed in this role, you should bring:

•    An MSc in a relevant field (e.g., pharmacy, life science etc).  
•    Solid experience in pharmaceutical products manufacturing with a strong quality background in driving or approving quality records like Change Controls, Deviations, and CAPAs.  
•    Familiarity with external manufacturing networks and cooperation with third-party partners.  
•    Experience in manufacturing, MS&T, or Operational QA would be an added value.  
•    Strong interpersonal, project management, and indirect leadership skills.  
•    Agile, flexible, and collaborative mindset with excellent organizational and communication abilities.  
•    Fluency in English

Contact and 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.

Your New Team

You will join a collaborative and cross-functional Quality Support team that works closely with External Manufacturing, Quality departments, Supply Chain Operations, Product & Process Technology, RA, and external partners (CMOs). This role offers a great opportunity to work with diverse stakeholders, balance differing priorities, and drive strategic improvements in external manufacturing quality processes.  

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.

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