Director for Inspection Office
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Bagsværd
Do you want to grow your potential at an expert level in a truly international environment? Do you have profound GMP compliance experience and a proven track record from GMP inspections? If this sounds interesting, you might very well be our new Director – so seize this excellent opportunity for the next step in your life-changing career!
The position
As Director in Inspection Office, you will have a unique opportunity to set direction and provide consultation for line of business in all matters related to interpretations and implementation of cGMP. In this senior expert role, you will have a key role in managing and hosting inspections from regulatory authorities and have an active participation in inspection preparations as well as performing mock inspections. Your involvement in inspections will also include coaching the personnel involved in inspections and being able to share your knowledge by teaching internally in the department.
You will be in a senior role, where others will lean on your expertise. Thus, you will have a key role in providing compliance guidance to stakeholders to help remediation of compliance gaps by clarifying external expectations and identify best possible solutions. You are expected to ensure timely response to all kinds of GMP requests.
The role offers a high degree of independence and responsibility for taking initiative to improve GMP compliance, where required. Further you will represent Novo Nordisk in various governmental working groups and at conferences.
The position will require some international travelling days.
Qualifications
To be successful in this role, you should have: Extensive experience within quality and GMP at a specialist/leader level. GMP inspection experience, including DKMA, EMA and FDA interaction. Knowledge within medical device inspections and ISO 13485 is advantageous. Strong ability to work with diverse cross-functional colleagues. Excellent interpersonal and stakeholder management skills, with a preference for international work experience, business acumen, solid presentation skills, and the willingness and ability to lead during change, take initiative, be agile in actions, and embrace new ways of working. Fluency in written and spoken English, written and spoken Danish is advantageous. As a person, you are open and communicative, with the ability to reach out and engage with multiple stakeholders. Your positive attitude and proactive can-do behaviour energise your colleagues and stakeholders, ensuring engagement and commitment wherever you go. You enjoy knowledge sharing, and your quality mindset and solution focus is a natural part of you. The structure you are applying to tasks helps you prioritise even when things are moving fast. You appreciate the value of accurate and timely documentation as the essential safety and quality control parameter.
About the department
Inspection Office is a highly specialised area where you will join a team of 30 highly skilled, ambitious, and motivated specialists with the responsibility for handling all GMP inspections and notified bodies audits in as well as responsibility for the recall process and the corporate Batch records, review and release processes. We have a close collaboration with our stakeholders globally in spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world. Working at
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
If you have questions about the position, please call Vice President Peter Søtofte Elten +.
Deadline
20 November 2024. 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 resume or 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 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.
The position
As Director in Inspection Office, you will have a unique opportunity to set direction and provide consultation for line of business in all matters related to interpretations and implementation of cGMP. In this senior expert role, you will have a key role in managing and hosting inspections from regulatory authorities and have an active participation in inspection preparations as well as performing mock inspections. Your involvement in inspections will also include coaching the personnel involved in inspections and being able to share your knowledge by teaching internally in the department.
You will be in a senior role, where others will lean on your expertise. Thus, you will have a key role in providing compliance guidance to stakeholders to help remediation of compliance gaps by clarifying external expectations and identify best possible solutions. You are expected to ensure timely response to all kinds of GMP requests.
The role offers a high degree of independence and responsibility for taking initiative to improve GMP compliance, where required. Further you will represent Novo Nordisk in various governmental working groups and at conferences.
The position will require some international travelling days.
Qualifications
To be successful in this role, you should have:
About the department
Inspection Office is a highly specialised area where you will join a team of 30 highly skilled, ambitious, and motivated specialists with the responsibility for handling all GMP inspections and notified bodies audits in as well as responsibility for the recall process and the corporate Batch records, review and release processes. We have a close collaboration with our stakeholders globally in spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world. Working at
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
If you have questions about the position, please call Vice President Peter Søtofte Elten +.
Deadline
20 November 2024. 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 resume or 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 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 Bagsværd.
Jobbet er oprettet på vores service den 6.11.2024, 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.
- 06.11.2024
- Øvrige
- Bagsværd
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