QA Project Manager
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Søborg
Are you looking for an exciting opportunity to shape the quality strategy for drug development projects? We are seeking a highly motivated Chemistry, Manufacturing and Control (CMC) QA Project Manager to play a vital role in ensuring the quality and safety of our products for clinical trials.
Don't miss this chance to make a significant impact in a dynamic and innovative industry. Apply now for a life-changing opportunity!
The position
The CMC QA Project Management department consists of 12 highly skilled employees. Due to an increasing project portfolio, we are expanding and looking for new colleagues to be part of our team and cover the quality perspective in drug development projects across all the therapeutic areas in Novo Nordisk.
In this role, you will manage the quality perspective in CMC projects with high complexity. You will get a broad range of exciting challenges with an impact on the results for the SVP area feeding into your personal and professional development.
In this role, you will have the opportunity to:
• Take important decisions and oversee the quality of projects going into clinical trials until their hand-over to Product Supply.
• Serve as a QA Outsourcing Manager for Contract Manufacturing Organizations (CMOs)
• Drive, coordinate, and facilitate quality-related activities between the CMOs and colleagues in CMC, such as quality agreements and document reviews.
• Identify and contribute to strengthening and simplifying our working processes in CMC QA.
• Foster collaboration with our stakeholders.
Overall, this is a great opportunity to make a meaningful impact in the pharmaceutical industry and help drive the development of high-quality products. Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration.
Qualifications
To succeed in this role, we imagine that you:
• Hold a master’s degree in pharmacy, biotechnology or similar.
• Have solid experience from pharmaceutical companies, and profound knowledge of the important aspects of QA and GMP relevant regulations, requirements and guidelines for pharmaceutical development and production for clinical trials. You might have worked e.g. as a QA specialist or QA/CMC project manager within the field of QA and/or CMC.
• Have some experience with project management or project coordination.
• Are fully proficient in English.
Experience working with CMOs and/or Due Diligence will be an advantage for this position.
As a person, you are open-minded, quality- and goal-oriented, and eager to find solutions to complex challenges. Managing a large network of people is something that drives you. You have great collaboration and communication skills on all organizational levels and are a self-driven and independent person with a high sense of responsibility and initiative. You thrive working in a dynamic environment, where teamwork is on the top of the agenda, and you enjoy working with many different stakeholders.
About the department
CMC QA is the quality area which together with CMC Development ensures that quality is incorporated in all aspects of developing products for clinical trials and has the responsibility of creating quality agreements with contract manufacturers across the globe. CMC QA consists of 6 departments, hereof 4 operational departments, 1 support department, and 1 project management department (our), all based in the greater Copenhagen area.
In our department, we value teamwork and diversity, and we will make sure that you, as a new employee, feel welcome and integrated. Further, an individual training plan will be made for you together with your mentor. 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 – we’re all working to move the needle on patient care.
Contact
For further information, please contact Senior Manager Tenna Aggerholm Møller at +45 3448 7725
1 March 2024
Please, note that applications will be reviewed, and interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible.
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.
Don't miss this chance to make a significant impact in a dynamic and innovative industry. Apply now for a life-changing opportunity!
The position
The CMC QA Project Management department consists of 12 highly skilled employees. Due to an increasing project portfolio, we are expanding and looking for new colleagues to be part of our team and cover the quality perspective in drug development projects across all the therapeutic areas in Novo Nordisk.
In this role, you will manage the quality perspective in CMC projects with high complexity. You will get a broad range of exciting challenges with an impact on the results for the SVP area feeding into your personal and professional development.
In this role, you will have the opportunity to:
• Take important decisions and oversee the quality of projects going into clinical trials until their hand-over to Product Supply.
• Serve as a QA Outsourcing Manager for Contract Manufacturing Organizations (CMOs)
• Drive, coordinate, and facilitate quality-related activities between the CMOs and colleagues in CMC, such as quality agreements and document reviews.
• Identify and contribute to strengthening and simplifying our working processes in CMC QA.
• Foster collaboration with our stakeholders.
Overall, this is a great opportunity to make a meaningful impact in the pharmaceutical industry and help drive the development of high-quality products. Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration.
Qualifications
To succeed in this role, we imagine that you:
• Hold a master’s degree in pharmacy, biotechnology or similar.
• Have solid experience from pharmaceutical companies, and profound knowledge of the important aspects of QA and GMP relevant regulations, requirements and guidelines for pharmaceutical development and production for clinical trials. You might have worked e.g. as a QA specialist or QA/CMC project manager within the field of QA and/or CMC.
• Have some experience with project management or project coordination.
• Are fully proficient in English.
Experience working with CMOs and/or Due Diligence will be an advantage for this position.
As a person, you are open-minded, quality- and goal-oriented, and eager to find solutions to complex challenges. Managing a large network of people is something that drives you. You have great collaboration and communication skills on all organizational levels and are a self-driven and independent person with a high sense of responsibility and initiative. You thrive working in a dynamic environment, where teamwork is on the top of the agenda, and you enjoy working with many different stakeholders.
About the department
CMC QA is the quality area which together with CMC Development ensures that quality is incorporated in all aspects of developing products for clinical trials and has the responsibility of creating quality agreements with contract manufacturers across the globe. CMC QA consists of 6 departments, hereof 4 operational departments, 1 support department, and 1 project management department (our), all based in the greater Copenhagen area.
In our department, we value teamwork and diversity, and we will make sure that you, as a new employee, feel welcome and integrated. Further, an individual training plan will be made for you together with your mentor. 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 – we’re all working to move the needle on patient care.
Contact
For further information, please contact Senior Manager Tenna Aggerholm Møller at +45 3448 7725
1 March 2024
Please, note that applications will be reviewed, and interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible.
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 Søborg.
Jobbet er oprettet på vores service den 1.8.2023, 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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