Quality Principal Scientists supporting new facilities
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Novo Nordisk is establishing new, ground-breaking biotech facilities utilising modern technology with fully automated operations and digitalised processes. Would you like to be part of expanding our capacities to support the company portfolio of future oral and injectable pharmaceuticals and to bring new innovative treatments to patients worldwide? In the quality organisation supporting the capacity expansions, we are looking for Quality principal scientists within the fields of Validation, Quality Risk Management & Risk Processes, Design & Implementation & Project Quality Assessments. The above positions will be in quality assurance of design and construction of mammalian cell culture, fermentation process, purification processes, facilities, process and utility equipment as well as aseptic- and finished production. The facilities will be situated in Denmark and abroad. The facilities are for pharmaceutical production and must be designed in accordance with cGMP requirements (current Good Manufacturing Practice) Qualifications The below competencies and skills are key to success in both roles, to gain a more specific insight on differences between the two positions please read more in the next section. We are looking for someone who has: A Master’s degree within science or equivalent Extensive experience from the pharmaceutical industry In depth knowledge of QA, GMP requirements and production Full English proficiency Strong communication skills Experience from project management or execution will be seen as an advantage, especially in big construction projects. These roles will have you be at the centre of leading and decision making in a high complexity landscape for building and then develop and maintain new facilities, for this reason the ideal candidate has a robust personality, is good at building relations and creating trust and is able to proactively set clear direction within the quality agenda. On a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, when the waves get high. You thrive in a multicultural environment working across organisational borders and management levels. Building structures comes naturally to you and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner. The positions Project Quality Assessor
You will be performing Project Quality Assessments and driving improvements and change across the investment project portfolio. You will assess project readiness and execution performance, providing knowledge and sparring to the projects and flag inherent risks in the projects in the early phases of the projects and during construction and validation. In the role as Project Quality Assessor you will be in close collaboration with your colleagues and stakeholders across the global investment portfolio. It is important that early direction for cGMP is clear, when laying down the first ‘stones’ in the plans for new facilities and before executing the projects in large scale. You will be part of a QA team reporting to a QA department manager.
Specific qualifications for Project Quality Assessments: Demonstrated experience with execution or management of pharma projects In depth knowledge of cGMP requirements and especially the ‘current’ as our facilities most be built to meet future regulatory expectations Preferably experience within auditing and stakeholder management Quality Principal Scientist:
You will be connected to one or more investment projects, where your deep knowledge will come into play, when designing solutions for new facilities, starting from the very early phases, and continuing all the way through to final validation and transferring the facilities into operation. As a principal scientist you will be reporting to a QA department manager.
Specific qualifications for Quality Principal Scientists: Deep knowledge and demonstrated experience of topics like supplier evaluation, equipment qualification, process validation, quality risk management, HVAC, environmental monitoring, cleaning validation, automation, and IT Ability to communicate the above topics to project teams and set direction for how to implement according to requirements Join Novo Nordisk in times of expansion Join us on our journey into the future and make your mark on a newly established organisation that will be growing in the coming years.
Join us if you would like to work with dedicated and experienced QAs for biotech professionals, if you are curious about the opportunity to establish a factory that bridges new and automated technologies with strong know-how and expertise in biotech manufacturing; and if you are interested in starting up the new facility and when built become part of the team supporting production of the new products. Contact If you require further information, please call Morten Skov Nørgaard on +45 30796553 Deadline 15 December 2023 We will process applications as we receive them, so please do not hesitate to apply. For us to react fast and accurately, please indicate clearly in your application which position(s) you are applying for. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your 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.
You will be performing Project Quality Assessments and driving improvements and change across the investment project portfolio. You will assess project readiness and execution performance, providing knowledge and sparring to the projects and flag inherent risks in the projects in the early phases of the projects and during construction and validation. In the role as Project Quality Assessor you will be in close collaboration with your colleagues and stakeholders across the global investment portfolio. It is important that early direction for cGMP is clear, when laying down the first ‘stones’ in the plans for new facilities and before executing the projects in large scale. You will be part of a QA team reporting to a QA department manager.
Specific qualifications for Project Quality Assessments:
You will be connected to one or more investment projects, where your deep knowledge will come into play, when designing solutions for new facilities, starting from the very early phases, and continuing all the way through to final validation and transferring the facilities into operation. As a principal scientist you will be reporting to a QA department manager.
Specific qualifications for Quality Principal Scientists:
Join us if you would like to work with dedicated and experienced QAs for biotech professionals, if you are curious about the opportunity to establish a factory that bridges new and automated technologies with strong know-how and expertise in biotech manufacturing; and if you are interested in starting up the new facility and when built become part of the team supporting production of the new products. Contact If you require further information, please call Morten Skov Nørgaard on +45 30796553 Deadline 15 December 2023 We will process applications as we receive them, so please do not hesitate to apply. For us to react fast and accurately, please indicate clearly in your application which position(s) you are applying for. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your 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.
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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 9.11.2023, 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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