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QA Specialist with experience in biotechnology and quality oversight of external partners

Do you want to use your process knowledge within biotechnology to practice quality oversight of our Contract Manufacturing Organizations?

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics.
Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing & Suppliers Quality department and contribute to activities within Supplier Quality Management related to the coming biotechnological products.

In External Manufacturing & Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job

The job is a new position established to strengthen our knowledge within biopharmaceutical drug substance and drug product manufacturing. Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs.

You will

  • build and share knowledge related to area of responsibility
  • practice quality oversight of externally manufactured products, including establishment and update of quality agreements between LEO Pharma and CMOs
  • perform confirmation of partial manufacturing of intermediate or bulk products manufactured by LEO Pharma’s contract manufacturers and make final batch release of contract manufactured products
  • act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders
  • participate in different projects related to outsourcing activities

Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs.

Your qualifications

  • Preferably a Masters’ degree in natural science, for example pharmacist or engineer
  • Many years of experience from the pharmaceutical industry
  • Solid and up-to-date knowledge of biopharmaceutical drug substance and drug product processes and with drug-device combination products
  • Solid and up-to-date knowledge of GMP requirements
  • Experience from working within a quality organization and preferably also experience as qualified person (QP)

You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset.

Your new team

External Manufacturing & Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient Suppliers, packaging suppliers, service providers and more.
We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing & Suppliers Quality at + 45 5352 6265.

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