Quality Partner with project management skills
Måløv
Do you have a good quality mindset and like to put pieces together, based on your experience? Do you want to join us on our journey unfolding an ambitious strategy for external QC analysis for drug substances and drug products? If so, this might be the right opportunity for you! We are looking for a talented Quality Partner for our newly established Manufacturing Development department for External QC analysis. The Position As Quality Partner in External Analysis & QC you get to be part of starting up a new and different QC Manufacturing Development department. You will be involved in defining processes and shaping the future collaboration with our stakeholders, both within Novo Nordisk and with external parties, such as Contract Manufacturing Organizations (CMO) and acquired companies.
You will report to the Director and be part of the management team, which currently consists of two team leads and the director. The teams are located in Denmark and in the US.
The main tasks will include:
• Defining and developing quality standards for the department to achieve simplicity, alignment and/or build quality into the processes.
• Supporting the understanding/alignment of quality standards across Novo Nordisk and the different CMOs and acquired companies
• Coordinating and driving department projects within quality
• Run workshops as a facilitator or participate as a hands-on executing resource writing SOPs and guides
• Define training needs and standards for the department
This position is in Måløv, Denmark, with a move to Taastrup, Denmark from the 1st of September. Qualifications To succeed in this role, you should:
• Hold a Bachelor's, Master's or equivalent degree in Pharmacy, Biochemistry, Chemical Engineering, or other relevant scientific discipline
• Have experience with cGMP, ICH guidelines, Pharmacopoeia, and regulatory requirements
• Ideally have experience from a similar position
• You must be fluent in English – oral and written
• If possible, have experience in working with contract manufacturing and contract research organisations (CMO & CRO)
As a person, you are good at establishing relations with other people and communicating constructively. You enjoy working in project groups and have a high level of energy to drive yourself and your colleagues forward to deliver on milestones.
You work in a structured manner and find solutions that are robust and will ensure the correct quality level. Knowing when to be pragmatic and when to stand firm on requirements is expected.
As we are a new department it is expected that you are able and enjoy to research on solutions as well as perform tasks hands-on. About the Department Emerging Technologies - External Analysis & QC is a new department under construction, with a team in US and one in Danmark. The main task of the department is supporting the CMOs in analytical matters, ownership and life cycle management of analytical methods and validations for the respective drug substance and drug product. We work with synthetic peptides, oligonucleotides, and small molecules. We are involved from late phase 3 and have a growing pipeline of new products, many of which are based on emerging technology platforms coming in via internal development projects and externally acquired assets.
The department is a diverse international team consisting of - Analytical Project Managers, Senior Analytical Professionals, Analytical Professionals and a Laboratory Technician. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Siv Sönnichsen Præst ([email protected]), Director for External Analysis & QC. Deadline
26 May 2024 Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified. 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.
You will report to the Director and be part of the management team, which currently consists of two team leads and the director. The teams are located in Denmark and in the US.
The main tasks will include:
• Defining and developing quality standards for the department to achieve simplicity, alignment and/or build quality into the processes.
• Supporting the understanding/alignment of quality standards across Novo Nordisk and the different CMOs and acquired companies
• Coordinating and driving department projects within quality
• Run workshops as a facilitator or participate as a hands-on executing resource writing SOPs and guides
• Define training needs and standards for the department
This position is in Måløv, Denmark, with a move to Taastrup, Denmark from the 1st of September. Qualifications To succeed in this role, you should:
• Hold a Bachelor's, Master's or equivalent degree in Pharmacy, Biochemistry, Chemical Engineering, or other relevant scientific discipline
• Have experience with cGMP, ICH guidelines, Pharmacopoeia, and regulatory requirements
• Ideally have experience from a similar position
• You must be fluent in English – oral and written
• If possible, have experience in working with contract manufacturing and contract research organisations (CMO & CRO)
As a person, you are good at establishing relations with other people and communicating constructively. You enjoy working in project groups and have a high level of energy to drive yourself and your colleagues forward to deliver on milestones.
You work in a structured manner and find solutions that are robust and will ensure the correct quality level. Knowing when to be pragmatic and when to stand firm on requirements is expected.
As we are a new department it is expected that you are able and enjoy to research on solutions as well as perform tasks hands-on. About the Department Emerging Technologies - External Analysis & QC is a new department under construction, with a team in US and one in Danmark. The main task of the department is supporting the CMOs in analytical matters, ownership and life cycle management of analytical methods and validations for the respective drug substance and drug product. We work with synthetic peptides, oligonucleotides, and small molecules. We are involved from late phase 3 and have a growing pipeline of new products, many of which are based on emerging technology platforms coming in via internal development projects and externally acquired assets.
The department is a diverse international team consisting of - Analytical Project Managers, Senior Analytical Professionals, Analytical Professionals and a Laboratory Technician. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Siv Sönnichsen Præst ([email protected]), Director for External Analysis & QC. Deadline
26 May 2024 Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified. 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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Arbejdsstedet er beliggende i Måløv.
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- Øvrige
- Måløv