Principal Quality Specialist with passion for GCP
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Ballerup
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 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 Coordinate, support and follow-up on regulatory inspections and 3rd 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 GCPs 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 have 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 &/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 strong GCP experience and thorough knowledge in clinical trials and/or pre-clinical studies.
You should be familiar with quality regulations and have a broad understanding of the entire value chain.
If you have pharmacovigilance, 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 the department and influence on your own job.
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:
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 have 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 &/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 strong GCP experience and thorough knowledge in clinical trials and/or pre-clinical studies.
You should be familiar with quality regulations and have a broad understanding of the entire value chain.
If you have pharmacovigilance, 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 the department and influence on your own job.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 7.2.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Ballerup
- Søndag den 15. marts 2020
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| Dato | Alle jobs som produktspecialister |
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