Validation Strategy Lead
Novo Nordisk
Dato: for 15 timer siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Fuld tid
Are you an experienced project manager or manager with a passion for process validation and operational excellence? Do you thrive in dynamic environments where cross-functional collaboration and high-impact decisions are part of your daily routine? If you're ready to take on a key role in shaping the future of pharmaceutical manufacturing, this opportunity is for you.
Join us in Finished Product Manufacturing Science & Technology (FPMSAT) – specifically in the Assembly & Packaging (A&P) Strategic Support team. Here, your expertise will contribute directly to global capacity expansion projects, working with some of the most skilled professionals in the industry. This is a great chance to drive meaningful change in how we validate and scale up our production processes worldwide.
The position
As our new Strategy Lead for Validation of Finished Product Processes in Assembly and Packaging, you will work closely with manufacturing organizations globally across Novo Nordisk, as well as a head quarter units and a broad portfolio of project teams within FPMSAT.
Your primary responsibility will be to lead the operationalization of our strategies for implementation of standardized process validation within our global Assembly and Packaging programs and operations.
Your key tasks include:
Qualifications
To be successful in this role, we imagine that you have:
About The Department
Final Product Development & Manufacturing (FPDM) is a part of Novo Nordisk Product Supply, a global production network at the forefront of technology and quality production of pharmaceutical products. At FPDM, we not only manufacture all finished products for people living with serious chronic diseases, we also use our competencies to drive technology leadership and improve standards across our core technologies to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk.
Our global network consists of around 6,000 colleagues across ten countries. Here, we are responsible for the manufacturing of all finished products, including devices, needles, assembly, and packaging. As more and more people need our products, we support Novo Nordisk's initiatives in new therapy areas. Every day, we strive to streamline and expand our capacity through process innovation, automation, and the introduction of new technology.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
For further information, please contact Senior Manager, Hans Kristian Rømer Westh, at +45 30796795.
Deadline
6 July.
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 to 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.
Join us in Finished Product Manufacturing Science & Technology (FPMSAT) – specifically in the Assembly & Packaging (A&P) Strategic Support team. Here, your expertise will contribute directly to global capacity expansion projects, working with some of the most skilled professionals in the industry. This is a great chance to drive meaningful change in how we validate and scale up our production processes worldwide.
The position
As our new Strategy Lead for Validation of Finished Product Processes in Assembly and Packaging, you will work closely with manufacturing organizations globally across Novo Nordisk, as well as a head quarter units and a broad portfolio of project teams within FPMSAT.
Your primary responsibility will be to lead the operationalization of our strategies for implementation of standardized process validation within our global Assembly and Packaging programs and operations.
Your key tasks include:
- Drive strategy implementation and be part of strategy development within Validation to support efficient and robust validation of Assembly and Packaging lines.
- Facilitate forum of cross organizational validation experts in the planning and preparation of documents, templates and procedures to support standardization for efficiency, harmonization and simplification.
- Partnering with validation experts and project managers to develop modern approaches to validation that ensure harmonization and simplification across A&P.
- Ensuring that documents and templates are aligned with internal and external requirements, including Novo Nordisk’s quality management system and validation process building on a science- and risk-based approach, regulatory requirements, and in line with Fill & Finish Expansion (FFEx) Quality strategy.
- Driving the implementation of clear roles and responsibilities and coordinating implementation and training across programs and projects.
- Communicating effectively with stakeholders at all levels to ensure alignment and transparency.
Qualifications
To be successful in this role, we imagine that you have:
- An academic degree within Natural Science, Engineering or a related field
- Extensive experience working with process validation experts as a manager or project manager in a pharmaceutical manufacturing environment.
- Knowledge of external regulations for aseptic products, medical devices and finished products e.g. as anchored in the Novo Nordisk Quality Management System.
- Expertise in process validation and regulatory compliance.
- Proficiency in both spoken and written English.
- Experience working with external partners, as well as management experience is considered a strong advantage.
About The Department
Final Product Development & Manufacturing (FPDM) is a part of Novo Nordisk Product Supply, a global production network at the forefront of technology and quality production of pharmaceutical products. At FPDM, we not only manufacture all finished products for people living with serious chronic diseases, we also use our competencies to drive technology leadership and improve standards across our core technologies to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk.
Our global network consists of around 6,000 colleagues across ten countries. Here, we are responsible for the manufacturing of all finished products, including devices, needles, assembly, and packaging. As more and more people need our products, we support Novo Nordisk's initiatives in new therapy areas. Every day, we strive to streamline and expand our capacity through process innovation, automation, and the introduction of new technology.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
For further information, please contact Senior Manager, Hans Kristian Rømer Westh, at +45 30796795.
Deadline
6 July.
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 to 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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