CMC QA Senior Integration Manager
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Are you looking for an exciting QA role where you can use your expertise in a cross functional collaboration within Mergers and Acquisitions (M&A)? Do you have passion for ensuring quality compliance in the integration of development projects? Do you want to make a real impact on the expansion of Novo Nordisk portfolio and the lives of patients with diabetes and other chronic diseases? Then read more and apply to join us!
The position
As a QA Integration Manager, you will play a pivotal role in the acquisitions and integration of new companies and development projects into Novo Nordisk in close collaboration with Chemistry, Manufacturing and Control (CMC) and the Novo Nordisk Quality (NNQ) integration organization. Your broad and extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance in integration project strategies and development plans. In this Manager role, you will be leading processes rather than people.
Your main responsibilities will be to:
• Represent CMC QA during transitional periods in merger and acquisitions
• Provide advice and directions to the integration strategies and transition activities during due diligence and M&A
• Act as CMC QA Function Lead in NNQ Quality Management System Integration projects
• Plan, coordinate and follow up on QA integration project activities to ensure timely delivery
• Proactively address potential quality problems in development projects If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you.
You can expect a 0-15 days of travel per year to visit new partners globally.
Qualifications
We are looking for someone with in depth knowledge of pharmaceutical product development, CMC activities, Investigational medicinal product (IMP), SGMP requirements and a broad knowledge of related areas within regulatory, development and production of pharmaceuticals and/or analytical/QC work. To succeed in this role, you:
• Hold a master’s degree in Pharmacy, Chemistry, biology, Engineering or similar
• Have extensive experience in a QA role within product development in the pharmaceutical industry
• Are fluent in English, both written and spoken
The ideal candidate also has project management and M&A experience within an international environment, these aspects will be considered an advantage but are not required.
On a personal level, you are a self-driven and strong team player with excellent analysis and problem-solving skills, other than solution oriented and with a can-do attitude with a strategic focus.
You have a structured way of working but are willing to lead during change, can take initiative, are agile in actions and embrace new ways of working. Finally, your excellent communication skills allow you to engage at all levels of the organization, act proactively and make independent decisions.
About the department
CMC QA Integration is a new team with the overall QA responsibility for M&A taking over from due diligence and deal, drive the transition, initial integration and handover to the CMC QA Project organization.
You will become a strong player in our small dynamic team consisting of competent people with a long experience within product development and quality assurance of IMP. The department is characterised by a high level of professionalism, flexibility, and cooperation.
We can offer a great working environment with high level of team spirit as well as a highly skilled team of ambitious and engaged colleagues. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area while forming the team. We focus on good social relations and prioritise to make room for fun at work.
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 QA Director Jane Saxbøl on +45 30 75 86 19 or QA Principal Integration manager Dorthe Bruun +45 30 79 86 7 Deadline
7 February 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.
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 position
As a QA Integration Manager, you will play a pivotal role in the acquisitions and integration of new companies and development projects into Novo Nordisk in close collaboration with Chemistry, Manufacturing and Control (CMC) and the Novo Nordisk Quality (NNQ) integration organization. Your broad and extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance in integration project strategies and development plans. In this Manager role, you will be leading processes rather than people.
Your main responsibilities will be to:
• Represent CMC QA during transitional periods in merger and acquisitions
• Provide advice and directions to the integration strategies and transition activities during due diligence and M&A
• Act as CMC QA Function Lead in NNQ Quality Management System Integration projects
• Plan, coordinate and follow up on QA integration project activities to ensure timely delivery
• Proactively address potential quality problems in development projects If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you.
You can expect a 0-15 days of travel per year to visit new partners globally.
Qualifications
We are looking for someone with in depth knowledge of pharmaceutical product development, CMC activities, Investigational medicinal product (IMP), SGMP requirements and a broad knowledge of related areas within regulatory, development and production of pharmaceuticals and/or analytical/QC work. To succeed in this role, you:
• Hold a master’s degree in Pharmacy, Chemistry, biology, Engineering or similar
• Have extensive experience in a QA role within product development in the pharmaceutical industry
• Are fluent in English, both written and spoken
The ideal candidate also has project management and M&A experience within an international environment, these aspects will be considered an advantage but are not required.
On a personal level, you are a self-driven and strong team player with excellent analysis and problem-solving skills, other than solution oriented and with a can-do attitude with a strategic focus.
You have a structured way of working but are willing to lead during change, can take initiative, are agile in actions and embrace new ways of working. Finally, your excellent communication skills allow you to engage at all levels of the organization, act proactively and make independent decisions.
About the department
CMC QA Integration is a new team with the overall QA responsibility for M&A taking over from due diligence and deal, drive the transition, initial integration and handover to the CMC QA Project organization.
You will become a strong player in our small dynamic team consisting of competent people with a long experience within product development and quality assurance of IMP. The department is characterised by a high level of professionalism, flexibility, and cooperation.
We can offer a great working environment with high level of team spirit as well as a highly skilled team of ambitious and engaged colleagues. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area while forming the team. We focus on good social relations and prioritise to make room for fun at work.
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 QA Director Jane Saxbøl on +45 30 75 86 19 or QA Principal Integration manager Dorthe Bruun +45 30 79 86 7 Deadline
7 February 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.
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 23.1.2024, 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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