Senior GMP Compliance Expert
2 weeks ago
The Role
As Director of Quality and Compliance for Inspection Office at Novo Nordisk, 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.
Your responsibilities will include providing compliance guidance to stakeholders to help remediation of compliance gaps by clarifying external expectations and identifying best possible solutions. You are expected to ensure timely response to all kinds of GMP requests.
Responsibilities
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.
Requirements
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.
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.
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