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Senior Qa Professional For Quality Oversight Of Contract Manufacturing Organisations, Søborg

Denmark, Denmark, Søborg
Udgivet 2024-06-11
Udløber 2024-06-11
ID #2189459257
Senior Qa Professional For Quality Oversight Of Contract Manufacturing Organisations, Søborg
Denmark, Denmark, Søborg,
Udgivet June 11, 2024


The position As a QA Professional you will be responsible for quality assurance of contract manufacturing and will be responsible for one or more CMO`s.

You will have to offer QA support and GMP guidance to our partners and do the final release of the API and intermediates from CMO`s to the further process in Novo Nordisk. Also, you will be responsible for: Ensuring that our outsourced products are manufactured according to c GMP and our marketing authorisations.

Daily interactions with internal and external business partners, involving complex tasks.

Handling a wide variety of tasks and facing daily challenges.

Oversight of QA activities typically conducted by contract manufacturers.

Managing documentation from contract manufacturers as part of the role.

Since the manufacturers are located outside Denmark, you are expected to travel 15-20 days a year.

Qualifications To succeed in this role, you should: Hold an academic degree as a Pharmacist, Engineer, or similar.

Possess at least four years of experience in a pharmaceutical organization and demonstrate solid and up-to-date knowledge of quality and GMP requirements.

Have Experience in handling Non-Conformity (NC), Corrective Actions and Preventive Actions (CAPA), change control, complaints, Annual Product Review (APR), and validations.

Ideal candidate is a Qualified Person (QP) delegate and/or has thorough knowledge of quality assurance of pharmaceutical manufactured products.

Proficiency in both Danish and English.

With your strong cooperation and communication skills you are able to organise and drive tasks.

You have a pragmatic approach to problem solving and strong interpersonal skills.

You are detail-oriented with a strong quality mind set and are a team player but are also able to work independently.

You thrive on working across departments in an international organisation.

About the department Global Contract Manufacturing Drug Substance QA (GCM DS QA) is a dynamic department consisting of 40 competent colleagues and is characterised by a high level of professionalism, flexibility and cooperation.

The primary role of our department is to deliver QA support and oversight and set direction for our CMO´s worldwide. We focus on good social relations and well-being in the team and prioritise to make room for fun at work.

Our department is currently located in Søborg, Denmark, with plans of moving to the new Novo Nordisk site in Taastrup, Denmark, in December.

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, employees.

Together, we go further.

Together, we’re life changing.


Jobtype: Fuld tid
Kontrakttype: Permanent
Løn type: Månedlige
Beskæftigelse: Senior qa professional for quality oversight of contract manufacturing organisations

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