Quality & Compliance Specialist
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Gentofte
Experienced with conducting phase I clinical trials? Have a solid understanding of GCP?
Then read more as this could be a perfect opportunity for you!
Come join us and help build the CLINiC, Novo Nordisk Clinical Innovation Centre! The position
You will work closely with other CLINiC Quality and Compliance Specialist, GCP expert and Risk Manager colleagues to help design and continuously develop CLINiC’s overall quality management system (QMS). You will use your knowledge of GCP and phase I clinical trials to review and approve Standard Operating Procedures (SOPs), as well as perform internal compliance audits.
Among your daily tasks, you will:
• Speak, educate, and engage your CLINiC colleagues in a way that supports a continuous and thriving quality culture
• Take the lead on quality compliance and quality management review activities
• Support structured risk management activities
• Perform various quality management reviews and checks
• Conduct training in relevant processes and legislation You will also oversee and support equipment maintenance, calibrations, expiry management, etc. as well as deviations, Corrective Actions and Preventive Actions (CAPAs) and external audits/inspections managing the follow-up. Qualifications
To succeed in this role, you can recognize yourself in the following:
• You have 1-3 years of hands-on experience working within phase 1 clinical research
• Solid knowledge of GCP
• Expertise in applicable quality standards and pharmaceutical process and value chain understanding
• Strong communication skills in written and spoken English
As a person, you have a strong sense of detail, a quality mindset, and the ability to navigate complexity, provide direction and assess compliance. You thrive in a changing and dynamic work environment and have a can-do attitude with the ability to prioritize, execute and follow up in a proactive and timely manner. You are a team player and a strong collaborator across the organization. About the department
You will become part of our CLINiC Quality department located in Gentofte, Denmark. The CLINiC is currently under development and will be responsible for conducting multiple clinical pharmacology trials with trials of an explorative nature, ultimately conducting First Human Dose studies. The CLINiC works closely with various partners within Novo Nordisk as well as externally across the Danish life science ecosystem. The CLINiC is part of Global Translation, where we drive all clinical development of products from early development phases to product introduction and life cycle management. Historically, all Novo Nordisk phase 1 trials have been outsourced to CROs. Looking into the future with Novo Nordisk entering new therapeutic areas, there are increased requirements for agility and early decision-making and a need to complement the current set-up with new options for early phase and exploratory development. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, contact Head of Quality Roland Foster at +45 3075 2817. Deadline
24 March 2023 If you can recognize yourself in the description above, please apply rather today than tomorrow, as we call for interviews on an ongoing basis and close the position as soon as we find the right candidate. You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process.
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.
Then read more as this could be a perfect opportunity for you!
Come join us and help build the CLINiC, Novo Nordisk Clinical Innovation Centre! The position
You will work closely with other CLINiC Quality and Compliance Specialist, GCP expert and Risk Manager colleagues to help design and continuously develop CLINiC’s overall quality management system (QMS). You will use your knowledge of GCP and phase I clinical trials to review and approve Standard Operating Procedures (SOPs), as well as perform internal compliance audits.
Among your daily tasks, you will:
• Speak, educate, and engage your CLINiC colleagues in a way that supports a continuous and thriving quality culture
• Take the lead on quality compliance and quality management review activities
• Support structured risk management activities
• Perform various quality management reviews and checks
• Conduct training in relevant processes and legislation You will also oversee and support equipment maintenance, calibrations, expiry management, etc. as well as deviations, Corrective Actions and Preventive Actions (CAPAs) and external audits/inspections managing the follow-up. Qualifications
To succeed in this role, you can recognize yourself in the following:
• You have 1-3 years of hands-on experience working within phase 1 clinical research
• Solid knowledge of GCP
• Expertise in applicable quality standards and pharmaceutical process and value chain understanding
• Strong communication skills in written and spoken English
As a person, you have a strong sense of detail, a quality mindset, and the ability to navigate complexity, provide direction and assess compliance. You thrive in a changing and dynamic work environment and have a can-do attitude with the ability to prioritize, execute and follow up in a proactive and timely manner. You are a team player and a strong collaborator across the organization. About the department
You will become part of our CLINiC Quality department located in Gentofte, Denmark. The CLINiC is currently under development and will be responsible for conducting multiple clinical pharmacology trials with trials of an explorative nature, ultimately conducting First Human Dose studies. The CLINiC works closely with various partners within Novo Nordisk as well as externally across the Danish life science ecosystem. The CLINiC is part of Global Translation, where we drive all clinical development of products from early development phases to product introduction and life cycle management. Historically, all Novo Nordisk phase 1 trials have been outsourced to CROs. Looking into the future with Novo Nordisk entering new therapeutic areas, there are increased requirements for agility and early decision-making and a need to complement the current set-up with new options for early phase and exploratory development. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, contact Head of Quality Roland Foster at +45 3075 2817. Deadline
24 March 2023 If you can recognize yourself in the description above, please apply rather today than tomorrow, as we call for interviews on an ongoing basis and close the position as soon as we find the right candidate. You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process.
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.
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 9.1.2023, 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
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Statistik over udbudte jobs som øvrige i Gentofte
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Statistik over udbudte øvrige i Gentofte over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 6. november 2024 | 17 |
| 5. november 2024 | 15 |
| 4. november 2024 | 19 |
| 3. november 2024 | 19 |
| 2. november 2024 | 19 |
| 1. november 2024 | 19 |
| 31. oktober 2024 | 17 |
| 30. oktober 2024 | 16 |
| 29. oktober 2024 | 16 |
| 28. oktober 2024 | 16 |
| 27. oktober 2024 | 18 |
| 26. oktober 2024 | 18 |
| 25. oktober 2024 | 16 |
| 24. oktober 2024 | 19 |
| 23. oktober 2024 | 20 |
| 22. oktober 2024 | 20 |
| 21. oktober 2024 | 20 |
| 20. oktober 2024 | 25 |
| 19. oktober 2024 | 26 |
| 18. oktober 2024 | 25 |
| 17. oktober 2024 | 26 |
| 16. oktober 2024 | 24 |
| 15. oktober 2024 | 21 |
| 14. oktober 2024 | 20 |
| 13. oktober 2024 | 21 |
| 12. oktober 2024 | 21 |
| 11. oktober 2024 | 22 |
| 10. oktober 2024 | 23 |
| 9. oktober 2024 | 21 |
| 8. oktober 2024 | 21 |
| 7. oktober 2024 | 22 |