Advanced QA Professional within Global Contract Manufacturing

7 days ago

Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

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Advanced QA Professional within Global Contract Manufacturing

Category: Quality

Location:
Bagsværd, Capital Region of Denmark, DK

Are you looking for a place to feed your enthusiasm for quality? And are you excited about playing a crucial role in ensuring quality processes in Novo Nordisk's global network of Contract Manufacturing Organizations (CMOs)?

Then you can look forward to a QA role in Global Contract Manufacturing Drug Substance (GCM DS) where your efforts can make a positive and direct impact for the patients every day.

You will participate in the Quality Oversight of our CMOs for Active Pharmaceutical Ingredients (API) and Drug Substance (DS) and you will be working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks.

The position
In this position you will be responsible for Quality Assurance of Contract Manufacturing and will be responsible for one or more CMOs with various products being produced for Novo Nordisk.

The QA role includes:

  • The quality responsibility for ensuring that our products are manufactured according to cGMP and our Marketing Authorizations.
  • Numerous encounters daily with both internal and external business partners and a high level of complexity in your daily tasks. You should also contribute to continuous improvements of our processes and strive for simplicity without compromising quality.
  • Handling of documentation from the contract manufacturers is a part of the job and you are also expected to participate in audits performed at the CMO and ensure sufficient follow up on CAPAs.
  • QA support and GMP guidance to our partners and final release of the products from CMOs to the further process in Novo Nordisk.
  • Expected travel is around 10-15 days a year as the CMOs are located outside Denmark primarily Europe and US.

If you are looking for a job which can foster the development of your professional and personal competences, this is your opportunity.

Qualifications
You hold an academic degree as Pharmacist, Engineer or similar and have minimum three years of experience from the pharmaceutical industry either from production or QA, where you have gained a solid and up-to-date knowledge of quality and GMP requirements.

To succeed in this role you should:

  • Hold an academic degree as a Pharmacist, Engineer, or similar.
  • Possess a minimum of three years of experience in the pharmaceutical industry, preferably in production or QA.
  • Have gained a solid and up-to-date knowledge of quality and GMP requirements.
  • Have great communication and collaboration skills and speaks and writes English fluently.

As a person, you have a natural ability to take responsibility and work as a team player, proactively contributing to the team's tasks and activities. Additionally, you have the ability to work in an international set-up with external stakeholders who may have different interests and agendas. Furthermore, you meet your own deadlines and understand how to effectively prioritize between different tasks in an ever-changing environment.

About The Department
The GCM Drug Substance QA area is responsible for quality assurance and quality support to outsourced production activities worldwide.

GCM DS QA is a dynamic area consisting of around 50 competent people with focus on either operations or projects. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our area is to deliver QA support and set direction for our global CMOs.

We focus on good social relations and prioritize to make room for fun at work. We have a great team spirit, and it is important for us that you will be a part of it.

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 career 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 Lena Ellen Larsen +45 30756471.

Deadline
9 February 2025.
We will review the applications and conduct interviews on an ongoing basis, so we encourage you to apply as soon as possible.
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.

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