LEO Pharma has embarked on an exciting journey to increase collaboration with third parties both in development and commercial manufacture. Would you like to join us on that journey? Do you have experience with GMP auditing and partnership management?

Affiliates & External Suppliers Quality
The Affiliates and External Suppliers Quality Unit works with quality within LEO affiliate companies worldwide and with our GMP and GDP regulated third parties. Third parties are suppliers, contract manufacturers, contract laboratories and distributors. We work with third parties both regarding development and commercial manufacturing. We perform due diligence, establish quality agreements, perform audits and follow up on third party quality performance.

We work closely together with our internal stakeholders in Sourcing, Logistics, External Manufacturing and Partnership Management to ensure quality and compliance within our supply chain. We participate in projects concerning new third parties and supply chain improvements.

Our department comprises 15 enthusiastic colleagues located in Ballerup, Dublin and Parsippany.

Affiliates & External Suppliers Quality is part of the Global Quality & EHS organisation with a total of 170 employees worldwide.

As our new Quality Specialist your primary responsibilities will be:

• evaluation of new partnerships as member of a cross functional team
• participation in projects involving third party interactions
• GMP audit of suppliers and contract manufacturers as part of projects
• establishment of Quality Agreements with new partners
• maintenance and development of the QMS with focus on third party compliance
• quality support to our internal stakeholders

Your profile:

• you have a master degree in one of the natural sciences (e.g. pharmacy, engineering, chemistry)
• you have a minimum of 5 years’ experience from the pharmaceutical industry and a strong quality mind-set
• you enjoy working with fast-paced strategic projects where your engagement matters
• you have experience working with suppliers and/or external partners
• experience as an auditor is a plus but experience from pharmaceutical development, manufacture or quality operations can also be the starting point
• you enjoy working together with people from different cultures and understand that there may be more than one compliant solution
• you are pragmatic and enjoy finding value adding solutions
• you are able to travel at least 40 days per year worldwide

We look forward to receiving your application.