QA Project Manager
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Are you motivated by defining the quality strategy for all drug development projects in our pipeline ensuring the quality from early development until submission to the authorities? Do you want to play an important role in ensuring the quality and safety of products for clinical trials? Then this position as Chemistry, Manufacturing and Control (CMC) QA Project Manager is for you! Read more and apply now! The position
CMC QA Project Management department consist 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 developments projects across all the therapeutic areas in Novo Nordisk. You will manage the quality perspective in CMC projects with high complexity. You will get a broad range of exciting challenges with impact on the results for the SVP area feeding in to your personal and professional development. Among your main responsibilities, you will: • use your empowerment to take decisions
• have the responsibility and quality oversight for projects going into clinical trials until hand-over to Product Supply
• act as an QA Outsourcing Manager to contract manufacturer organisations (CMOs), where you will
• drive, coordinate and facilitate quality related activities (e.g quality agreements, document review etc.) between the CMOs and colleagues in CMC
• identify and contribute to strengthening and simplify our working processes in CMC QA and towards our stakeholders Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration. Qualifications
We are looking for a colleague that has QA and Project Management experience with profound knowledge of the important aspects of CMC and GMP relevant regulations, requirements and guidelines for pharmaceutical development and production for clinical trials. To succeed in this role, you: • hold a master’s degree within pharmacy, biotechnology or similar
• have solid experience within pharmaceutical companies, preferably from roles such as QA specialist or QA/CMC project manager within the field of QA and/or CMC
• preferably have some project management experience
• are fully proficient in English Experience from working with CMO’s and/or Due Diligence will be an advantage for this position. As a person, you are open-minded and quality-and goal-oriented, eager to find solutions on complex challenges. Managing a large network of people is something that drives you.
You have great collaboration and communication skills on all organisational 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 consist of 6 departments, hereof 4 operational departments, 1 support department and 1 project management department (our), all based in greater Copenhagen area. In our department, we value teamwork and diversity, and we will make sure 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
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers 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 Senior Manager Tenna Aggerholm Møller at +45 3448 7725 Deadline
2 July 2023 Review of applications and interview will be held ongoing, so we encourage you to apply sooner rather than later. 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.
CMC QA Project Management department consist 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 developments projects across all the therapeutic areas in Novo Nordisk. You will manage the quality perspective in CMC projects with high complexity. You will get a broad range of exciting challenges with impact on the results for the SVP area feeding in to your personal and professional development. Among your main responsibilities, you will: • use your empowerment to take decisions
• have the responsibility and quality oversight for projects going into clinical trials until hand-over to Product Supply
• act as an QA Outsourcing Manager to contract manufacturer organisations (CMOs), where you will
• drive, coordinate and facilitate quality related activities (e.g quality agreements, document review etc.) between the CMOs and colleagues in CMC
• identify and contribute to strengthening and simplify our working processes in CMC QA and towards our stakeholders Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration. Qualifications
We are looking for a colleague that has QA and Project Management experience with profound knowledge of the important aspects of CMC and GMP relevant regulations, requirements and guidelines for pharmaceutical development and production for clinical trials. To succeed in this role, you: • hold a master’s degree within pharmacy, biotechnology or similar
• have solid experience within pharmaceutical companies, preferably from roles such as QA specialist or QA/CMC project manager within the field of QA and/or CMC
• preferably have some project management experience
• are fully proficient in English Experience from working with CMO’s and/or Due Diligence will be an advantage for this position. As a person, you are open-minded and quality-and goal-oriented, eager to find solutions on complex challenges. Managing a large network of people is something that drives you.
You have great collaboration and communication skills on all organisational 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 consist of 6 departments, hereof 4 operational departments, 1 support department and 1 project management department (our), all based in greater Copenhagen area. In our department, we value teamwork and diversity, and we will make sure 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
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers 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 Senior Manager Tenna Aggerholm Møller at +45 3448 7725 Deadline
2 July 2023 Review of applications and interview will be held ongoing, so we encourage you to apply sooner rather than later. 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 12.6.2023, 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.
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