Quality Specialist in R&D Quality
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Søborg
Are you the go-to GMP specialist in your area and you are ready to be challenged with something new? Are you passionate about quality and simplicity? Bring your passion and skills and join our diverse & inclusive quality department as our new Quality Specialist.
The position
We are looking for an experienced Quality Specialist to join our GS & RA Quality department in R&D Quality, located in Søborg.
If you have a solid GMP expertise, strong experience with Quality processes and quality risk management, and believe that simple processes give high compliance and efficiency, then join us and influence the processes owned in GS and RA.
Your core responsibilities will be to:
You will be part of a dynamic area with many transformation initiatives, where you are expected to take great ownership and responsibility to setting the right quality bar in the global organisation.
Qualifications
You hold a relevant scientific academic degree, e.g., pharmacy, medicine, science or equivalent and a strong command of written and spoken English.
On top of that you:
We value a candidate with an eye for details, yet at the same time being able to set things in perspective and see the big picture. The perfect candidate will be known for their high-quality work, positive attitude, and ability to quickly obtain an overview of a given subject.
About the department
R&D Quality is part of the Development organisation and plays a vital role in supporting the drug and device development process to ensure high quality as well as fit-for-purpose processes throughout the entire value chain.
The open position is in the Global Safety (GS) & Regulatory Affairs (RA) Quality department responsible for Quality support and Quality Management System activities across all processes in GS and RA areas. We are a very divers quality department which support a large organization and with global stakeholder interaction. We are QAs for deviations, SOPs, change controls, quality monitoring, process reviews, and we are quality partners in transformational projects within Global Safety and Regulatory Affairs areas. We work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.
We are busy and are on an exciting journey bringing quality on top of the agenda throughout the R&D organisation – and maybe you are the one to join us on this journey?
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, through to manufacturing, marketing, and sales.
Contact
For further information, please contact Lavinia G. M. Pedersen: +45 30799636.
Deadline
08 January 2023.
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 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.
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The position
We are looking for an experienced Quality Specialist to join our GS & RA Quality department in R&D Quality, located in Søborg.
If you have a solid GMP expertise, strong experience with Quality processes and quality risk management, and believe that simple processes give high compliance and efficiency, then join us and influence the processes owned in GS and RA.
Your core responsibilities will be to:
- be the Quality partner in transformational projects like TRACK and NextGen - securing compliance with GxP regulatory requirements
- lead process risk analysis and together with the process managers, apply Quality expertise to mitigate process gaps and improve process performance
- support in assessment of new changes, new requirements, new therapeutic areas, drug - device - software combination, IVD, stem cells, etc.
- lead and manage quality process improvements and be the enabler for new complex circumstances in GS and RA areas
- facilitate workshops, to share knowledge within the department and across R&D Quality, to engage the organisation by building the right level of compliance, readiness, and ownership around the optimisations to come
You will be part of a dynamic area with many transformation initiatives, where you are expected to take great ownership and responsibility to setting the right quality bar in the global organisation.
Qualifications
You hold a relevant scientific academic degree, e.g., pharmacy, medicine, science or equivalent and a strong command of written and spoken English.
On top of that you:
- have worked extensively with GMP regulated processes and compliance and have 6+ years of working experience within quality assurance or quality management processes. The position requires significant insight into Quality/ QMS processes, quality requirements (GxP), ISO13485, and other relevant regulations
- have knowledge and great interest within digitalisation, data analysis, new technologies
- have experience with facilitating workshops from e.g., project management will be an advantage
- are proactive, curious, and courageous by nature
- have a pragmatic and diplomatic approach to stakeholder resistance or challenges. Where others see barriers and problems you find solutions that are smart, and you can easily explain these to your peers. The job requires excellent stakeholder management and communication skills including the ability to explain and describe complex subjects in an easy and understandable way
We value a candidate with an eye for details, yet at the same time being able to set things in perspective and see the big picture. The perfect candidate will be known for their high-quality work, positive attitude, and ability to quickly obtain an overview of a given subject.
About the department
R&D Quality is part of the Development organisation and plays a vital role in supporting the drug and device development process to ensure high quality as well as fit-for-purpose processes throughout the entire value chain.
The open position is in the Global Safety (GS) & Regulatory Affairs (RA) Quality department responsible for Quality support and Quality Management System activities across all processes in GS and RA areas. We are a very divers quality department which support a large organization and with global stakeholder interaction. We are QAs for deviations, SOPs, change controls, quality monitoring, process reviews, and we are quality partners in transformational projects within Global Safety and Regulatory Affairs areas. We work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.
We are busy and are on an exciting journey bringing quality on top of the agenda throughout the R&D organisation – and maybe you are the one to join us on this journey?
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, through to manufacturing, marketing, and sales.
Contact
For further information, please contact Lavinia G. M. Pedersen: +45 30799636.
Deadline
08 January 2023.
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 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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 10.12.2022, 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
- Søborg
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