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Quality Expert

2 weeks ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

As a Quality Partner at Novo Nordisk A/S, you will play a vital role in ensuring the highest quality standards across our Emerging Technologies API Manufacturing Development (ET API MDev) department.

This is an exciting opportunity to join a newly established team and contribute to building the quality coordination network. You will work closely with subject matter experts to drive strategic quality improvement initiatives and support management in setting the direction for the department on quality challenges and opportunities.

Key responsibilities include acting as a one-point-of-entry for audits and inspections, driving the planning and execution of these events, and ensuring overall inspection readiness. Additionally, you will support the yearly planning of quality activities and strengthen and maintain the training setup in the department.

In this role, you will be the go-to person on quality subjects and actively identify and drive quality improvement projects using systematic problem-solving, process mapping, or other Lean methodologies.

About the Department

You will be assigned to ET API MDev within Product Supply organization, working at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management.

This is a multidisciplinary project environment where you will have the opportunity to work with other highly qualified and motivated colleagues.

Requirements

To succeed in this role, you must have an academic degree as a Pharmacist, Engineer, Scientist, or similar, or equivalent knowledge through relevant practical experience.

You should also have a minimum of 2 years' experience within GxP guidelines and regulations and current legislation, as well as proficiency in both spoken and written English.

This role requires strong communication and collaboration skills, the ability to take responsibility, work independently, and make decisions that balance quality requirements, authority expectations, and business needs.