id: NDkzNzk3MyA3

reference: 4937973

documentId: 4937973

connectionPointId: 7

lastModificationDate: 1548848890256

stillingsbetegnelse:
Principal Quality Specialist with passion for GCP and PV

jobbeskrivelse:

Would you like to play a key role in LEOs ambitious clinical trial programme? Do you find it exiting to cooperate with colleagues across functional areas? Are you looking for a job where you can get global responsibility and personally impact a new team with a super ambitious agenda? Then, this is the job for you! 

The job

You will be part of the Global Quality Business Partner team where you will be working closely together with internal and external stakeholders to ensure LEO’s processes and systems are maintained and in line with regulatory expectations and industry best practice.

In overview your primary responsibilities will be to:

• Provide quality expertise and advice to stakeholders on matters related to GCP and PV
• Coordinate, support and follow-up on regulatory inspections and 3^rd party inspections
• Participate and contribute as quality representative in projects
• Communicate and assess the impact of regulatory/industry practice changes on stakeholders systems, LEO studies/projects, data and patients
• Develop and deliver training in relevant GxPs and LEO Quality Systems

You will work across the global organisation and be in contact with numerous people in multiple departments and functions. As part of this, you can also expect minimum 10 travel days per year to meet colleagues and partners.

The job is a new position with reference to the Director of External & Support Quality.

About the department

We are a newly established department with the responsibility of being the quality one point of contact to our stakeholders in LEO. Our stakeholders range from Clinical Operations and PV to IT and LEO affiliates around the world. 

The goal is to provide best-in-class quality expertise, facilitate knowledge sharing and develop  pragmatic solutions for potential compliance deficiencies and/or improvements.

You will join a team of dedicated and energetic senior specialists in an informal work environment where everyone is heard.

Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun!

Your qualifications

You are a graduate in pharmacy, engineering or chemistry with thorough knowledge in several pharmaceutical disciplines – clinical trials, pharmacovigilance and/or pre-clinical studies - and quality regulations, or equivalent a broad knowledge of all areas combined with deep expert knowledge in one pharmaceutical discipline and quality regulation.

If you have combination product and/or audit experience, it will naturally benefit your application.

You are a “self-starting” and highly structured person that is able to plan own work and get things finished on time. Working cross-organisational takes strong communication and collaboration skills – in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.

Excellent written and oral communication skills. Ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.

What are you getting in return?

By joining the team you will have a unique opportunity for personal and professional development and to contribute to business critical processes. Furthermore, the possibility to have an impact on a newly established department and influence on your own job.

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

In case you are interested, you can get more information from Director Arslan Nejadi +45 41 77 21 05.

Please submit your CV and application no later than February 10th 2019.

We look forward to receiving your application.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

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