id: NDk1MjI5OCA3

reference: 4952298

documentId: 4952298

connectionPointId: 7

lastModificationDate: 1551423129690

stillingsbetegnelse: Senior Manager – Regulatory Affairs Compliance

jobbeskrivelse:

Help us reset our Quality Management System and take our global compliance to the next level

If you are an expert within regulatory compliance and you are looking for an opportunity to personally influence the setup in a successful and growing global company, this is the job of your dreams. LEO Pharma has set out to become the world’s preferred dermatology care partner. As part of this, we will simplify and harmonise our Regulatory Affairs (RA) quality framework in a global set up. And this is where you enter the scene with all of your entrepreneurial spirit, your quality mindset and your passion for making a difference that really matters.

Quality management, process development, training, deviation handling, advisory…

You will join a newly established team at LEO Pharma’s headquarter in Ballerup, Greater Copenhagen. Together, we will reset our RA Quality Management System (QMS) with the clear-cut ambition to make it best-in-class – easy to use and easy to maintain and thereby secure global compliance. You will play a key role in this operation. The challenge only becomes more interesting since we have to do it while we at the same time handle the daily operation as support unit to our colleagues in Global Regulatory Affairs. Your primary tasks will be:

• Reset our RA Quality Management System
• Manage RA processes owned by RA – facilitate, (co-)write, review, approve, revise…
• Manage deviations and non-conformities including CAPA handling
• Develop and ensure maintenance of the training matrix
• Develop and offer/conduct adequate and sufficient training of RA colleagues
• Ensure inspection readiness within RA – coordinate, support, participate and follow-up
• Follow up on Quality Management Reviews

You will also unfold your skills and ideas in compliance related projects with the resetting of our QMS as the first and most prominent.

Solid RA experience including quality management and compliance

You have a Master’s degree within natural science backed by 5+ years Regulatory Affairs or QA experience from a GxP environment. As such, you have acquired a deep understanding of the regulatory framework and procedures in a global setting with emphasis on quality management and regulatory compliance. This includes understanding of how RA contributes to the drug development process as well as life-cycle management. 

You will need your entrepreneurial spirit and a strong drive for the most optimal results. As part of a support team you must like to help other people and do it with due respect to professional and cultural differences – we can only succeed if we think and act like one great RA team. As part of this, you can communicate in an easy understandable and motivating way that makes your audience understand and support your recommendations.

We look forward to receiving your application.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C1219

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR