Quality Assurance Project Manager
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Gentofte
Are you thrilled about working in a global project environment with a high energy level and do you have experience with regulatory strategies, interaction with health authorities and product transfers?
Then you might be the Quality Assurance Specialist (QA) we are looking for to support the establishment of our new aseptic production (AP) sites across the world. Apply today and join us!
The position
As QA Specialist in AP Expansions Quality, you will be the link between AP Expansions and Regulatory Affairs for all regulatory aspects from the early phase of the projects until the health authority approval of the new facilities, as well as a key contributor to the following:
You will be reporting to the CVP for AP Expansions Quality.
Some international travel will be required.
Qualifications
To succeed in this role, we expect you to have a strong pharmaceutical business understanding including solid understanding and analysis of regulatory options and risks, as well as:
As a person you are a team player, well organised and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure. You are a skilled communicator who can cooperate at any organisational level and feel at ease engaging in strategic discussions and making independent decisions
About the department
AP Expansions Quality belongs in the newly established area AP Expansions. The new area is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.
We want to rethink our way of aseptic production and build something we can be proud of – also in 20 years from now.
Our department has a global responsibility for quality assurance and compliance of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. We have an international collaboration with QA for the new facilities.
You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here – to ensure that people can lead a life independent of chronic disease.
Contact
For further information, please contact Senior Manager, Tine Møller Jørgensen at +45 3079 1621 or CVP, Birgitte Rømer Rassing at +45 3075 3818.
Deadline
Please submit your application no later than 20 December 2022. Please note that interviews may start before the deadline, so feel free to submit your application as soon as possible.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
Then you might be the Quality Assurance Specialist (QA) we are looking for to support the establishment of our new aseptic production (AP) sites across the world. Apply today and join us!
The position
As QA Specialist in AP Expansions Quality, you will be the link between AP Expansions and Regulatory Affairs for all regulatory aspects from the early phase of the projects until the health authority approval of the new facilities, as well as a key contributor to the following:
- Develop the regulatory strategy together with Regulatory Affairs for implementing new aseptic production lines across our production sites. You will have a close collaboration with Regulatory Affairs and Quality Intelligence & Inspection
- Involved in the planning of interaction and dialogue with the health authorities like DKMA/EMA, NMPA and FDA for Type C meetings or similar
- Member of the project group who is planning product transfers
- Responsible for the site master file(s)
- Planning and coordination of audits and inspections
You will be reporting to the CVP for AP Expansions Quality.
Some international travel will be required.
Qualifications
To succeed in this role, we expect you to have a strong pharmaceutical business understanding including solid understanding and analysis of regulatory options and risks, as well as:
- A Master’s degree in Pharmacy, Engineering, Biology, Chemistry or similar.
- Experience within regulatory processes and interaction with health authorities.
- Experience with product transfers.
- Experience in project management and strategic planning.
- Strong quality mindset and result orientation.
- Proficiency in English, speaking and writing.
As a person you are a team player, well organised and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure. You are a skilled communicator who can cooperate at any organisational level and feel at ease engaging in strategic discussions and making independent decisions
About the department
AP Expansions Quality belongs in the newly established area AP Expansions. The new area is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.
We want to rethink our way of aseptic production and build something we can be proud of – also in 20 years from now.
Our department has a global responsibility for quality assurance and compliance of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. We have an international collaboration with QA for the new facilities.
You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here – to ensure that people can lead a life independent of chronic disease.
Contact
For further information, please contact Senior Manager, Tine Møller Jørgensen at +45 3079 1621 or CVP, Birgitte Rømer Rassing at +45 3075 3818.
Deadline
Please submit your application no later than 20 December 2022. Please note that interviews may start before the deadline, so feel free to submit your application as soon as possible.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 26.4.2022, 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.
- Øvrige
- Gentofte
Lignende jobs
-
Projektchef – NCC Infrastructure DK, Fjernvarmepro...
Fri kontaktBrænder du for at motivere og lede mennesker? Kan du koordinere mellem alle parter af et bygge- og anlægsprojekt og sikre, at alle udfører deres arbejde til punkt og prikke? Vil du præge fremtidens fjernvarmeprojekter? Kleven & Partners søger for NCC. Du vil stå i spidsen for store fjernvarmeprojekter.Få mere info- Øvrige
- Gentofte
-
Øvrige i Allerød
Få mere info- Øvrige
- Allerød
-
Øvrige i Holte
Få mere info- Øvrige
- Holte
-
Øvrige i Kongens Lyngby
Få mere info- Øvrige
- Kongens Lyngby
Statistik over udbudte jobs som øvrige i Gentofte
Herunder ser du udviklingen i udbudte øvrige i Gentofte over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.
Se flere statistikker her:
Statistik over udbudte øvrige i Gentofte over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 28. september 2024 | 31 |
| 27. september 2024 | 28 |
| 26. september 2024 | 28 |
| 25. september 2024 | 26 |
| 24. september 2024 | 23 |
| 23. september 2024 | 25 |
| 22. september 2024 | 27 |
| 21. september 2024 | 27 |
| 20. september 2024 | 27 |
| 19. september 2024 | 27 |
| 18. september 2024 | 26 |
| 17. september 2024 | 24 |
| 16. september 2024 | 23 |
| 15. september 2024 | 32 |
| 14. september 2024 | 28 |
| 13. september 2024 | 31 |
| 12. september 2024 | 30 |
| 11. september 2024 | 32 |
| 10. september 2024 | 28 |
| 9. september 2024 | 26 |
| 8. september 2024 | 32 |
| 7. september 2024 | 27 |
| 6. september 2024 | 33 |
| 5. september 2024 | 33 |
| 4. september 2024 | 27 |
| 3. september 2024 | 26 |
| 2. september 2024 | 23 |
| 1. september 2024 | 21 |
| 31. august 2024 | 23 |
| 30. august 2024 | 22 |
| 29. august 2024 | 21 |