Quality Project Lead
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Do you want to play a crucial role in ensuring quality processes in our network of Local Contract Manufacturer Organisations? Do you thrive in a job with lots of professional cross organisational interfaces working with projects with many stakeholders across different cultures?
Then this is a great opportunity to become a part of one of Novo Nordisk’s most interesting QA teams in Local Manufacturing QA (LM QA), contract manufacturing team in Bagsværd Denmark. Read more and apply now!
The position
In this position you will be QA Lead in outsourcing Manufacturing processes from Novo Nordisk to Contract Manufacturer Organisations (CMOs). This work will include being QA for e.g., Technical Transfer and Quality assessments of current and new CMO´s. You will participate in various projects working with both internal stakeholders across Novo Nordisk and working with external business partners and you must expect a high level of complexity and independent decision making in your daily tasks.
Some of your main tasks will be:
• Be responsible for the technical transfer to the CMOs
• Take lead to ensure the CMO Quality Management System (QMS) is sufficient to fulfil relevant GMP requirements
• Manage quality issues during the technical transfer and during ramp up for production
• Negotiate and advise on requirement interpretation and implementation of quality agreements, approving validation strategy and related documents as well as setting up the QA processes for commercial manufacturing
• Participate in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs
You will be expected to travel around 25 days a year as the manufacturers is located outside Denmark. Your base will be in the Copenhagen area in Denmark.
Qualifications
We are looking for an open-minded person with an outgoing attitude and natural networking skills, who can perform on different organisational levels.
To succeed in this role, you:
• hold an academic degree as Pharmacist, Engineer or similar
• have some years of experience from the pharmaceutical industry, preferably from aseptic production or QA
• have solid knowledge of quality, EU GMP regulation and requirements
• are fluent in English
It will be an advantage, but not a prerequisite, if you have experience working with CMOs and if you have experience working with projects.
On a personal level, you have a natural ability to take lead and work as a team player, and proactively contribute to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, still meeting you own deadlines and know how to prioritise between different tasks in an everchanging environment.
We would enjoy welcoming a straightforward person with a good sense of humour to our department.
About the department
In LM QA contract manufacturing we are responsible for quality assurance of Novo Nordisk’s outsourced production for local markets in e.g., India and Bangladesh. We ensure product quality from CMOs directly out to the market and patients and has the ultimately opinion in batch release.
We are working in an international environment in close collaboration with the CMOs and internal stakeholders across Novo Nordisk. We believe that strong relations with trust and mutual respect drives the good collaboration and a sustainable impact. The team consist of 9 highly skilled people working closely together as well as having high impact on decisions individually.
Our performance is driven by engagement and ambitious goals and a wish to deliver highest quality to patients, improve and simplify our way of working while having quality and compliance in focus. Therefore, curiosity and courage are a key part of the job with focus on engagement, trust and mutual respect.
Working at Novo Nordisk
At Novo Nordisk, you will help millions of people who are living with diabetes. We expect high performance and the ambition to make your mark on our business. In exchange, we offer a wide range of opportunities for professional and personal development
Contact
For further information, please contact Peter Thomas Olesen on +45 3079 9728.
Deadline
8 January 2023
Please note that interviews will be held on an ongoing base, so we encourage you to apply before the deadline.
You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.
Print job Send to e-mail
Then this is a great opportunity to become a part of one of Novo Nordisk’s most interesting QA teams in Local Manufacturing QA (LM QA), contract manufacturing team in Bagsværd Denmark. Read more and apply now!
The position
In this position you will be QA Lead in outsourcing Manufacturing processes from Novo Nordisk to Contract Manufacturer Organisations (CMOs). This work will include being QA for e.g., Technical Transfer and Quality assessments of current and new CMO´s. You will participate in various projects working with both internal stakeholders across Novo Nordisk and working with external business partners and you must expect a high level of complexity and independent decision making in your daily tasks.
Some of your main tasks will be:
• Be responsible for the technical transfer to the CMOs
• Take lead to ensure the CMO Quality Management System (QMS) is sufficient to fulfil relevant GMP requirements
• Manage quality issues during the technical transfer and during ramp up for production
• Negotiate and advise on requirement interpretation and implementation of quality agreements, approving validation strategy and related documents as well as setting up the QA processes for commercial manufacturing
• Participate in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs
You will be expected to travel around 25 days a year as the manufacturers is located outside Denmark. Your base will be in the Copenhagen area in Denmark.
Qualifications
We are looking for an open-minded person with an outgoing attitude and natural networking skills, who can perform on different organisational levels.
To succeed in this role, you:
• hold an academic degree as Pharmacist, Engineer or similar
• have some years of experience from the pharmaceutical industry, preferably from aseptic production or QA
• have solid knowledge of quality, EU GMP regulation and requirements
• are fluent in English
It will be an advantage, but not a prerequisite, if you have experience working with CMOs and if you have experience working with projects.
On a personal level, you have a natural ability to take lead and work as a team player, and proactively contribute to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, still meeting you own deadlines and know how to prioritise between different tasks in an everchanging environment.
We would enjoy welcoming a straightforward person with a good sense of humour to our department.
About the department
In LM QA contract manufacturing we are responsible for quality assurance of Novo Nordisk’s outsourced production for local markets in e.g., India and Bangladesh. We ensure product quality from CMOs directly out to the market and patients and has the ultimately opinion in batch release.
We are working in an international environment in close collaboration with the CMOs and internal stakeholders across Novo Nordisk. We believe that strong relations with trust and mutual respect drives the good collaboration and a sustainable impact. The team consist of 9 highly skilled people working closely together as well as having high impact on decisions individually.
Our performance is driven by engagement and ambitious goals and a wish to deliver highest quality to patients, improve and simplify our way of working while having quality and compliance in focus. Therefore, curiosity and courage are a key part of the job with focus on engagement, trust and mutual respect.
Working at Novo Nordisk
At Novo Nordisk, you will help millions of people who are living with diabetes. We expect high performance and the ambition to make your mark on our business. In exchange, we offer a wide range of opportunities for professional and personal development
Contact
For further information, please contact Peter Thomas Olesen on +45 3079 9728.
Deadline
8 January 2023
Please note that interviews will be held on an ongoing base, so we encourage you to apply before the deadline.
You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.
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 Bagsværd.
Jobbet er oprettet på vores service den 7.12.2022, 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.
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