GMP & Validation Expert (Denmark, Kalundborg)

Jobbeskrivelse
Placering
Kalundborg, Denmark

Jobkategori
Manufacturing

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Novo Nordisk is expanding its manufacturing facilities in Kalundborg to support the portfolio within chronic diseases. We are hiring a GMP & Validation Expert for this project – also called the M3 Project. The activities will take place at our Kalundborg site, which is Novo Nordisk's hub for API manufacturing.

Are you interested in being a part of a dynamic global company and working on an exciting new project for capacity expansion? This opportunity involves establishing new active pharmaceutical ingredients (API) manufacturing facilities that integrate new and automated technologies with strong expertise in biotech manufacturing.

Apply today and join us for a life-changing career!

The position
As GMP & Validation expert (also called Project Quality Manager) you will be overall responsible for setting the quality direction for a new API production facility.

Furthermore, you will:

• participate in setting the direction on validation planning, design reviews, risk assessments, requirements for tests, qualification, and validation. A key design principle will be to copy existing design standards from other recent projects.
• exercise strong leadership to keep the team focused on execution instead of comprehensive design considerations.
• be an essential part of building a competent user organization, integrating with engineering partners, and collaborating with contractors while supervising their activities.
• coordinate quality activities across the project and introduce newcomers to the Novo Nordisk validation system, including the quality strategy, plans for design, qualification, and validation in the project.
• be part of preparing overall quality documents within the project.

Qualifications
To succeed in this role, you have:

• 6 years+ of experience within GMP and pharmaceutical (API) manufacturing.
• Master’s degree in pharmacy, chemistry, pharmaceutical process engineering, or similar.
• experience working with validation and projects within the pharmaceutical industry.
• English proficiency (verbal and written).
• strong and impactful communication skills- including teaching skills, and high quality mindset – being able to balance requirements against the fast progress of project activities.

On a personal level, you enjoy teamwork and are a strong motivator of others. You thrive in a multicultural environment that demands independence to make critical decisions. Building structure comes naturally to you, and you enjoy simplifying wherever simplicity can benefit in reaching the right goals faster.

About the department
We are a newly established department supporting the M3 project with specialist knowledge within GMP and validation throughout all project phases. We also support the entire area with training support during project phases and training development for the future operations.

We are currently approx. 20 employees and still growing. We have lots of fun at the same time as keeping up with the many questions from the M3 organisation around us.

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 Mie Boa Jacobsen (Senior Project Manager) at +45 30751354.

Deadline
7 April 2025

We care about your motivation, but 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 CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

For internal candidates from PS API please note that we will contact current manager before inviting candidates for first interview.

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.