Device expert to drive the future of our Quality Management System

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  • Quality
  • Bagsværd

Device expert to drive the future of our Quality Management System

Do you have a strong background and knowledge about GMP requirements related to medical device and combination products? And do you thrive in understanding regulatory requirements? Are you passionate about quality and want to help build the Quality Management System of the future? Would you like to cooperate with some of our most experienced process experts and interact with stakeholders across the organisation? If so, there is a unique job opportunity waiting for you.

About the department

Quality Processes, a part of Novo Nordisk Quality, is responsible for maintaining and continuously developing the core quality processes in Novo Nordisk (deviations, CAPA, Change control, Global Process Governance, QMR, QRM, Validation and Metrology) We are responsible for making sure our processes are in compliance with regulatory requirements and they operate as smoothly as possible. Our ambition is to build a robust and simple quality management system that can support Novo Nordisk in maintaining world class quality in the future.

The job

Your primary responsibility will be to ensure that our QMS have incorporated the requirements from 21CFR820, 21CFR4, MDR and ISO13485 in a way that’s makes it easy for employees to understand where the requirements originates from. It will also be your responsibility to assist the organisation during MDSAP inspections and other inspections with focus on device requirements. Further you will work as a process expert/or back up within the Quality processes one of the above processes (excluded validation and metrology). You will work closely together with your teammates on all the processes in the area. The process expert responsibilities include securing compliance with regulatory requirements, developing the process strategy and training strategy and together with the process owner, driving and developing the corporate process group.

To support our journey, it will also be part of your job to plan and facilitate workshops to engage the organisation by building the right level of readiness, energy and ownership around the optimisations to come.

This position provides a unique opportunity to impact the Quality Management System from the inside, and the improvement initiatives you will be leading, will have a great positive impact all across Novo Nordisk.

You will work anchored in Bagsværd, but in collaboration with stakeholders from all around the globe.

Qualifications

We envision a colleague with a minimum of 4-6 years of experience working with quality in Novo Nordisk and in special with the following regulations 21CFR820, 21CFR4, MDR & ISO13485. You have a master degree within pharmacy, engineering or similar and profound knowledge of GMP rules and extensive hands on experience with the quality management processes. Experience with facilitating workshops from e.g. project management will be an advantage.

Where others see barriers and problems you find solutions that are smart, - and you are able to easily explain these to your peers.

Your personal qualities define you as robust, structured, a self-starter and a great collaborator always having a positive attitude. You have an eye for the details, yet at the same time manage to set things in perspective and see the big picture. You are known for your high-quality work, your positive attitude and your ability to quickly obtain an overview of a given subject.

The job requires excellent stakeholder management and communication skills including the ability to explain and describe complex subjects in an easy and understandable way also in English.

Working at Novo Nordisk

In Novo Nordisk, you will be met with trust, interesting challenges and rich opportunity for personal and professional growth. You will be investing your unique skills in an environment focused around capable sparring and the sharing of knowledge, and where your talent and experience is valued. We are proud to use our dedication and our capabilities to make a difference for millions of people around the world.

Contact

For further information, please contact Kamilla Munk Petersen at +45 3079 6296.

Deadline

29. November 2020

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".

Arbejdsstedet er beliggende i Bagsværd.

Jobbet er oprettet på vores service den 17.11.2020, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktspecialist
  • Bagsværd
Rapportér

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