Senior QA for Local Manufacturing CMO projects
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Søborg
Do you want to be part of expanding our CMO business, to have international business impact and are you ready to make a difference for millions of patients? Are you passionate about Quality Assurance in the asepticf field and Quality Management Systems (QMS)? Do you want to work in one of the most interesting and challenging areas in Novo Nordisk and eager to take your professional career to the next step? If your answer is yes and you have the ability to engage, set quality and compliance direction and mobilize people with different cultural backgrounds in an ever-changing international setting, you could be our new colleague in our Local Manufacturing CMO team.
The job In this position, you will together with your very experienced QA colleagues take responsibility of ensuring quality and progress in our global export project portfolio. We are currently in Local Manufacturing bringing in new CMOs to produce insulin products for millions of patients globally. This is a fantastic opportunity to join a time of Local Manufacturing where new business areas are established. You will be involved and take lead in all project phases such as due diligence, establish good collaboration with CMOs, technology transfer, equipment/facility qualification, process validation. As the CMOs are located outside Denmark and you will be responsible for onsite activities at the CMO, you should expect about 2 month traveling per year (the first year could be more). As QA you will together with a highly skilled QA team be responsible for delivering best-in-class Quality Assurance and work with our colleagues in Line-of-Business to ensure highest quality at our CMOs production. You will take QA lead in market and capacity expansion projects and be responsible for setting the quality and compliance direction. You will during all project phases ensuring QA oversight, GMP compliance and progress. You will to ensure effective project execution and progress in ambitious timelines have frequent visits at the CMOs. You will set the quality direction and approve relevant documents during qualification of equipment and facility as well as validation of the production line, incl Aseptic, QC and packaging. You will promote good collaboration with the CMO as well as build the Quality mind-set and Quality and Compliance culture at the CMO, including activities such as to train the local CMO QA organization to maintain and improve compliant operation and to act as both coach and mentor at the CMO’s You have the ability to oversee and manage high level tasks in an international and often cultural and politically challenging environment You must have strong cross-functional skills as well as an ability to engage and energize local employees at the CMO’s You have experience and high level of knowledge within Quality Assurance, QMS and EU GMP. The position will be part of the organizational set-up in LM QA DK currently consisting of 10 colleagues located in the Danish office, 2 in India and 1 in Bangladesh, all working closely together. LM QA currently cover our CMO locations in Saudi Arabia, India, Bangladesh, Belarus and South Africa and we are currently exploring opportunities in other countries. We expect you to be able to handle situations independently, apply your subject matter knowledge, identify better practice, create improvements to processes, share knowledge and to let your colleagues learn and shine. Qualifications M.Sc within Pharmacy, Chemistry, Biotechnology Engineering, Science or similar. You have preferably a minimum of 6 years of relevant experience working with aseptic production in QA organizations within pharmaceutical manufacturing. You have experience with EU GMP requirements, business understanding within pharmaceutical products, qualification and validation, collaboration in international environment, relation building and stakeholder management. You are experienced user of SAP in a production environment. As a person, you have a high level of energy and drive, are open-minded and positive attitude, want to make a difference and are eager to learn. You have a well-developed Quality Mind-set and an ability to set direction, engage and energize employees in the task/challenge at hand You can understand and collaborate in an international environment with respect for cultural differences. You are diplomatic and have a mature appearance and style which demonstrates authority and good judgement You must be fluent in English, both written and spoken. Knowledge of other languages is an advantage.
About the department
Local Manufacturing QA (LM QA) is a part of Contract Manufacturing, Sourcing and Devices in Product Supply, Novo Nordisk A/S. LMQA is responsible for Quality Assurance of Novo Nordisk’s local manufacturing CMO’s and local NN sites. One of the primary roles of LM QA is to deliver QA support and set direction for Contract Manufacturing Organizations (CMO’s) in countries where local presence is required to maintain market access. The job is in Søborg, Denmark. Things move fast in our unit, and the daily operation is dependent on cooperation with many internal and external stakeholders from all over the world.
Working at Novo Nordisk
At Novo Nordisk, you will have the opportunity to build a life-changing career in a global business environment. From research and development, to manufacturing, marketing, and sales, we strive to improve quality of life for more than 400 million people living with diabetes or other diseases. Contact
For further information, please contact Senior Quality Manager Asger Laurberg Vig +45 30752770. Deadline April 3rd 2024 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.
Do you know someone?
If it is not the job for you, but perhaps you know someone who might fit and be interested, please share this job. Thank you for your referral. 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.
The job In this position, you will together with your very experienced QA colleagues take responsibility of ensuring quality and progress in our global export project portfolio. We are currently in Local Manufacturing bringing in new CMOs to produce insulin products for millions of patients globally. This is a fantastic opportunity to join a time of Local Manufacturing where new business areas are established. You will be involved and take lead in all project phases such as due diligence, establish good collaboration with CMOs, technology transfer, equipment/facility qualification, process validation. As the CMOs are located outside Denmark and you will be responsible for onsite activities at the CMO, you should expect about 2 month traveling per year (the first year could be more). As QA you will together with a highly skilled QA team be responsible for delivering best-in-class Quality Assurance and work with our colleagues in Line-of-Business to ensure highest quality at our CMOs production.
Local Manufacturing QA (LM QA) is a part of Contract Manufacturing, Sourcing and Devices in Product Supply, Novo Nordisk A/S. LMQA is responsible for Quality Assurance of Novo Nordisk’s local manufacturing CMO’s and local NN sites. One of the primary roles of LM QA is to deliver QA support and set direction for Contract Manufacturing Organizations (CMO’s) in countries where local presence is required to maintain market access. The job is in Søborg, Denmark. Things move fast in our unit, and the daily operation is dependent on cooperation with many internal and external stakeholders from all over the world.
Working at Novo Nordisk
At Novo Nordisk, you will have the opportunity to build a life-changing career in a global business environment. From research and development, to manufacturing, marketing, and sales, we strive to improve quality of life for more than 400 million people living with diabetes or other diseases. Contact
For further information, please contact Senior Quality Manager Asger Laurberg Vig +45 30752770. Deadline April 3rd 2024 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.
Do you know someone?
If it is not the job for you, but perhaps you know someone who might fit and be interested, please share this job. Thank you for your referral. 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 Søborg.
Jobbet er oprettet på vores service den 29.12.2023, 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.
- Øvrige
- Søborg
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