Specialist - Quality Management Systems

3 weeks ago


Måløv, Denmark Novo Nordisk AS - A1p Full time

Are you a specialist with a strong background in GMP and quality management in the pharmaceutical industry? Do you have a deep understanding in guidelines and how to operationalize them. If so, we have an exciting opportunity for you to join our Cell Therapy at Novo Nordisk. Read on to learn more and apply today for a life-changing career.
 
The position

As a Senior Professional in Quality Management Systems at Novo Nordisk, you will have the following responsibilities:

Implement guidelines requirements into the Quality Management System (QMS) and develop QMS for Cell Therapy CMC. Participate in audits and inspections internally to ensure compliance with quality and regulatory standards. Maintain and optimize the existing QMS system. Collaborate with cross-functional teams to create a combination product QMS for Cell Therapy. Standardize and simplify processes and procedures within the QMS. Provide training and support to ensure the successful implementation of processes.

Qualifications
To succeed in this role, you: Have minimum of 3 years of experience with quality management systems in the pharmaceutical industry.

Hold a master’s degree in the life science. Have strong knowledge of guidelines and GMP manufacturing. Have experience in implementing guidelines requirements into QMS and developing QMS. Familiarity with audits and inspections, both internal and external. Ability to maintain and optimize existing QMS systems. Fluency in written and spoken English.


As a person we are seeking for a proactive and solution-oriented colleague with the ability to share knowledge and work independently. 

About the department
The Cell Therapy Manufacturing Development department at Novo Nordisk is a small and dynamic team that takes joy in creating the stage-appropriate quality environment for our area to work in. We are dedicated to ensuring the quality level of everything we do in developing and manufacturing innovative cell therapies that have the potential to transform the lives of patients around the world. Join us in our mission to make a difference and contribute to the advancement of cell therapy.


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