Denmark Job Openings
Novo Nordisk
Director for Inspection Office
Bagsværd
November 8, 2024
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 c GMP. 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.
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 Novo Nordisk 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 Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world.
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.
If you have questions about the position, please call Vice President Peter Søtofte Elten +45 3079 8453.
Deadline
20 November 2024.
New Job Alerts
Aarhus Universitet
Postdoctoral in biophysical and structural characterization of auxin transport, Aarhus University, Denmark
Aarhus
FULL TIME
November 19, 2024
View Job DescriptionAarhus Universitet
Professor in Remote Sensing and GIS for Atmospheric Emission Monitoring and Modelling
Roskilde
FULL TIME
November 19, 2024
View Job DescriptionCOWI
Market Director, Buildings and Industry
Kongens Lyngby
FULL TIME
November 19, 2024
View Job DescriptionSTARK Danmark A/S
Junior Power Platform Consultant for STARK GROUP IT's CRM team
Stark
November 19, 2024
View Job DescriptionUnilode Aviation Solutions Denmark ApS
Tekniker
Dragør
FULL TIME
November 19, 2024
View Job DescriptionNovo Nordisk
Vice President, Attraction & Onboarding in Novo Nordisk Global Talent Acquisition
Bagsværd
November 19, 2024
View Job DescriptionNovo Nordisk
Global Project Manager - AP Implementation
Bagsværd
November 19, 2024
View Job DescriptionAstellas
Operational Effectiveness and Analytics Manager, Nordics
FULL TIME
November 19, 2024
View Job DescriptionLooking for similar job?
Pfizer
Site Care Partner (associate director) Denmark
Ballerup
FULL TIME
August 16, 2024
View Job DescriptionEuropean Energy A/S
Director, QHSE to wind, solar, and PtX projects
Søborg
August 19, 2024
View Job DescriptionThe LEGO Foundation
Director, Head of Knowledge Facilitation
Billund
August 11, 2024
View Job DescriptionSee What’s New: Novo Nordisk Job Opportunities
Novo Nordisk
Corporate Vice President for Biometrics - Cardiovascular, Kidney, Liver, Alzheimer's & Rare Disease
Søborg
November 19, 2024
View Job DescriptionNovo Nordisk
Director, DD&IT PS Technology Partnering
Ballerup
November 19, 2024
View Job DescriptionNovo Nordisk
Global Project Manager - AP Implementation
Bagsværd
November 19, 2024
View Job DescriptionNew Job Alerts
Aarhus Universitet
Postdoctoral in biophysical and structural characterization of auxin transport, Aarhus University, Denmark
Aarhus
FULL TIME
November 19, 2024
View Job DescriptionAarhus Universitet
Professor in Remote Sensing and GIS for Atmospheric Emission Monitoring and Modelling
Roskilde
FULL TIME
November 19, 2024
View Job DescriptionCOWI
Market Director, Buildings and Industry
Kongens Lyngby
FULL TIME
November 19, 2024
View Job DescriptionSTARK Danmark A/S
Junior Power Platform Consultant for STARK GROUP IT's CRM team
Stark
November 19, 2024
View Job DescriptionUnilode Aviation Solutions Denmark ApS
Tekniker
Dragør
FULL TIME
November 19, 2024
View Job DescriptionNovo Nordisk
Vice President, Attraction & Onboarding in Novo Nordisk Global Talent Acquisition
Bagsværd
November 19, 2024
View Job DescriptionNovo Nordisk
Global Project Manager - AP Implementation
Bagsværd
November 19, 2024
View Job DescriptionAstellas
Operational Effectiveness and Analytics Manager, Nordics
FULL TIME
November 19, 2024
View Job Description