Validation Strategy Lead - Medical Devices & Finished Pharmaceutical Products
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Hillerød
Pharmaceutical manufacturing has always pushed boundaries, but in this role, you’ll drive innovation by shaping global capacity expansion and transforming how we approach validation.Only through unordinary approaches that we can deliver extraordinary results.Your new role
As part of the A&P (Assembly & Packaging) Strategic Support team within FPMSAT (Finished Product Manufacturing Science & Technology), you will work closely with manufacturing organizations globally across , as well as a headquarter units and a broad portfolio of project teams.Your primary responsibility will be to lead the operationalisation of our strategies for implementation of standardised process validation within our global A&P programs and operations.
Your key daily tasks include:Driving strategy development and implementation within Medical Device/ Finished Product Validation to support efficient, robust validation of A&P lines Facilitating cross organisational forums to standardise validation practices through aligned template, procedures, and documentation Partnering with validation experts and project managers to develop modern approaches to validation that ensure harmonization and simplification across A&P Ensuring compliance and alignment of validation materials with internal QMS, regulatory requirements, and the Fill & Finish Expansion Quality strategy, using a science- and risk-based approach 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 Your new department
In CMC & Product Supply, we cover the full value chain from drug and device development to marketed products. We are more than 30,000 colleagues across the globe with the shared responsibility of scaling molecules, processes, devices, and products, dedicated to supplying life-saving medicines to the patients who need them most.Final Product Development & Manufacturing (FPDM) is a part of 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 .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 '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.Your skills and qualifications
The ideal candidate will have a strong background in the validation of medical devices, and finished products. Furthermore, you’ll bring with you:An academic degree within Natural Science, Engineering, or a related field Extensive experience working with medical device process validation experts as a manager or project manager in a pharmaceutical manufacturing environment Knowledge of external regulations for medical devices, finished products and aseptic products, e.g. as anchored in the QMS Expertise in process validation and regulatory compliance, e.g. in-depth knowledge of regulatory requirements for medical device validation (e.g., ISO 13485) Strong communication and collaboration skills, with the ability to seamlessly connect and inspire people while transforming challenges into opportunities Experience working with external partners, as well as management experience is considered a strong advantage.Working at
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination, and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.More information
For further information, please contact Senior Manager, Hans Kristian Rømer Westh, at Kindly be aware that the Hiring Manager will be on vacation week 29, 30 and 31, with limited availability via email.
Deadline
6 August 2025.Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
As part of the A&P (Assembly & Packaging) Strategic Support team within FPMSAT (Finished Product Manufacturing Science & Technology), you will work closely with manufacturing organizations globally across , as well as a headquarter units and a broad portfolio of project teams.Your primary responsibility will be to lead the operationalisation of our strategies for implementation of standardised process validation within our global A&P programs and operations.
Your key daily tasks include:
In CMC & Product Supply, we cover the full value chain from drug and device development to marketed products. We are more than 30,000 colleagues across the globe with the shared responsibility of scaling molecules, processes, devices, and products, dedicated to supplying life-saving medicines to the patients who need them most.Final Product Development & Manufacturing (FPDM) is a part of 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 .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 '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.Your skills and qualifications
The ideal candidate will have a strong background in the validation of medical devices, and finished products. Furthermore, you’ll bring with you:
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination, and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.More information
For further information, please contact Senior Manager, Hans Kristian Rømer Westh, at Kindly be aware that the Hiring Manager will be on vacation week 29, 30 and 31, with limited availability via email.
Deadline
6 August 2025.Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 21.6.2025, 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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