QMS Specialist - Integrations
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Bagsværd
Are you passionate about quality and want to help build the Quality Management System (QMS) of the future? Would you like to cooperate with some of our most experienced Process Managers and interact with stakeholders across the organization? Do you have excellent coordination skills and knowledge of Quality Management System from the pharma industry? If you can say yes to the above, then there is a unique job opportunity just for you.
About the department
Quality Processes, a part of Novo Nordisk Quality, is responsible for maintaining and continuously developing the core quality management processes and their supporting IT systems in Novo Nordisk. We are responsible for ensuring that our processes comply with the regulatory requirements, and that they operate as smoothly as possible. We also support QMS Integrations of Novo Nordisk Acquisitions. Our ambition is to build a robust and simple QMS, that can support Novo Nordisk in maintaining world class quality in the future. You will work with 12 committed team members and will report to the Senior Manager in QMS Operations. The position is anchored in Bagsværd, but in collaboration with stakeholders from all around the globe.
The position
You will work closely together with the Process Managers in the team, supporting QMS integrations and incoming compliance signals.
In this role, you will:
• Function as one point of entry for integration activities related to the department Quality Processes
• Represent Quality Processes in integration workstreams
• Establish integration activity plans for Quality Processes and follow up on activities
• Promote alignment across integration decisions related or impacting our processes
• Support alignment on compliance signals impacting the processes in scope of QMS Focus Group
• Support preliminary impact assessments of incoming compliance signals Moreover, together with Process Managers, you will identify regulations and raise relevant compliance signals related to products and technologies acquired by Novo Nordisk.
Qualifications
To succeed in this role, you:
• have a master’s degree within pharmacy, engineering or similar
• have several years of experience working with quality and have profound knowledge of GMP and Quality Management Systems from pharma industry.
• have experience with facilitating workshops e.g., project management will be an advantage
• are fluent in English On a personal level, you are robust, structured, a self-starter and a great collaborator always having a positive attitude. Finally, you have excellent stakeholder management, coordination and communication skills.
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. Contact If this opportunity sounds like a great fit for you, please contact Senior QMS Specialist Wilian Silveira at +45 30756404 or Senior Manager Stine Akselsen at +45 3075 7282 for further information. Deadline
23 October 2023.
Applications will be reviewed ongoing. 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 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.
About the department
Quality Processes, a part of Novo Nordisk Quality, is responsible for maintaining and continuously developing the core quality management processes and their supporting IT systems in Novo Nordisk. We are responsible for ensuring that our processes comply with the regulatory requirements, and that they operate as smoothly as possible. We also support QMS Integrations of Novo Nordisk Acquisitions. Our ambition is to build a robust and simple QMS, that can support Novo Nordisk in maintaining world class quality in the future. You will work with 12 committed team members and will report to the Senior Manager in QMS Operations. The position is anchored in Bagsværd, but in collaboration with stakeholders from all around the globe.
The position
You will work closely together with the Process Managers in the team, supporting QMS integrations and incoming compliance signals.
In this role, you will:
• Function as one point of entry for integration activities related to the department Quality Processes
• Represent Quality Processes in integration workstreams
• Establish integration activity plans for Quality Processes and follow up on activities
• Promote alignment across integration decisions related or impacting our processes
• Support alignment on compliance signals impacting the processes in scope of QMS Focus Group
• Support preliminary impact assessments of incoming compliance signals Moreover, together with Process Managers, you will identify regulations and raise relevant compliance signals related to products and technologies acquired by Novo Nordisk.
Qualifications
To succeed in this role, you:
• have a master’s degree within pharmacy, engineering or similar
• have several years of experience working with quality and have profound knowledge of GMP and Quality Management Systems from pharma industry.
• have experience with facilitating workshops e.g., project management will be an advantage
• are fluent in English On a personal level, you are robust, structured, a self-starter and a great collaborator always having a positive attitude. Finally, you have excellent stakeholder management, coordination and communication skills.
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. Contact If this opportunity sounds like a great fit for you, please contact Senior QMS Specialist Wilian Silveira at +45 30756404 or Senior Manager Stine Akselsen at +45 3075 7282 for further information. Deadline
23 October 2023.
Applications will be reviewed ongoing. 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 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.
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 23.6.2023, 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.
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