Quality Coordinator (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Quality

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Do you want to build and establish the right level of quality in an area within Novo Nordisk that bridges between early research and production? Do you like to have a broad stakeholder palette and securing everyone is on board regarding compliance and GMP?

Then apply now to be our next Quality Coordinator in CMC API Development!

The Position
As a Quality Coordinator you will be part of the QMS Team which is one-point-of-entry for securing and coordinating Quality Management System (QMS) activities from global procedures, being responsible for audits and inspections (conduct planning, execution, and follow-up) and support with quality and training related activities.

The main tasks will be to:

• Expand and build the QMS within Chemistry Manufacturing and Control (CMC) Active Pharmaceutical Ingredient (API) development
• Help with deviations and change requests
• Trend reporting/evaluation
• Quality monitoring setup
• Quality reporting documents owned at API Development level

You will strengthen the QMS by ensuring compliance of our working processes and procedures in the departments working with Good Manufacturing Practices (GMP). This involves actively participating in the planning, preparation, and execution of audits and inspections within API Development. Additionally, maintaining a thorough content overview and conducting meticulous security risk assessments are essential components of our strategy to uphold the highest standards of quality and safety in our operations.

Qualifications
To succeed in this role, you have:

• Scientific academic degree in engineering, biology, chemistry, or similar
• At least 3 years of experience within Quality (GMP) and compliance within pharma, food industry or similar
• The ability to manage competing timelines and priorities
• Problem-solving and coordination skills
• Experience with project management, including cross-functional communication and stakeholder management
• Excellent written and verbal communication skills in Danish and English

As a person, you are curious and have a quality mindset. You like to take responsibility, both within the team and independently. You make decisions that balance quality requirements, authority expectations, and business needs. You describe yourself as pragmatic with a proactive mindset and strong collaboration skills.

About the Department
The API QMS team is a part of the CMC Active Pharmaceutical Ingredients (API) Process Operations department, anchored in CMC API development, CMC API Process Operations plays a key role in securing the patient safety in the clinical trials from the entire Novo Nordisk development portfolio. Your new team formed in 2023 consist of 3 dedicated, knowledgeable caring and open-minded full-time employees, located in Søborg.

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 energise 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 Anne Torp at +45-30751844. (Not available from 11-17 July and 24 July - 28 August)

Deadline
Apply before July, 28 2024.

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.