Quality Lead Auditor (GMP/GDP)

Application deadline: 23-Oct-2024 
Location: Gdańsk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2531 

Are you an experienced quality professional ready to take on a pivotal role in ensuring compliance and excellence across a global organization? LEO Pharma is looking for a Quality Lead Auditor to join our Supplier & Audit Quality department in Gdansk, Poland. This is your chance to shape audit strategies, lead complex projects, and make a significant impact in a dynamic and forward-thinking environment. 

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 elevate your career and contribute to a company making a real difference, this opportunity is your gateway to a rewarding career!

In Supplier & Audit Quality 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 Quality Lead Auditor, you will be a key contributor to oversight of the audit risk assessment and the audit program for regulated LEO Pharma entities and the Supplier’s within the GMP/GDP area, respectively. 

Your main tasks include, but are not limited to:
•    Perform internal audits within GMP/GDP and Drug-Device-Combination products
•    Perform GMP/GDP and Drug-Device-Combination product audits at external suppliers/CMOs
•    Contribute to defining audit strategy of regulated LEO Pharma entities and Suppliers within GMP/GDP and Drug-Device-Combination product area
•    Perform internal and external audit risk assessment and ensure oversight of audit program
•    Evaluate quality questionnaires, handle change controls, deviations, CAPAs, and oversee document archiving 
•    Represent audit function in leading role during Authority Inspections
•    Update and significantly improve procedures, driving compliance improvements projects, compliance gab analysis and impact assessment
•    Create training material and perform training/knowledge sharing within the audit function

Your qualifications 

To succeed in this role, we imagine that you have the following qualifications:

•    Master’s Degree in Natural Science or similar
•    Experience and knowledge within GXP auditing 
•    Solid experience within a GMP/GDP/DDC regulated area with significant expertise within two or more of the following fields: drug device combination products, biologics, raw materials, drug substance, excipients, finished medicinal products (sterile and non-sterile), primary/secondary packaging materials, distribution, contract laboratories, CMO’s, service providers and investigational medicinal products. 
•    Profound knowledge of pharmaceutical production and the pharmaceutical industry
•    Fluency in English is a must

As our ideal candidate, you are able to plan and execute your work schedule. You are well-organized, you have an orientation towards details and quality mindset.
You have a strong understanding of fundamental business processes and their interactions, including the impact of external/internal influences on decision-making.  

Your new team
You will be part of an GMP/GDP audit team with 2 auditor colleagues located in Segrate and 2 in Denmark. Audit & GD Quality consists of a diverse, passionate, and uniquely skilled team of 13 individuals distributed across Europe.  

Contact and application
For additional information, please contact Louise Groth Persson, Supplier & Audit Quality Senior Manager, +45 53800591. 

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.