Senior Quality Operations Specialist

4 weeks ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a Senior Quality Operations Specialist to join our team at Novo Nordisk A/S in Kalundborg, Denmark. As a key member of our API Business Support department, you will play a crucial role in ensuring high-quality API products for our patients.

Job Summary

The Senior Quality Operations Specialist will be responsible for driving quality and compliance initiatives across the CVP area. This includes collaborating with management teams, conducting trend analysis, participating in quality-related networks, and coordinating audits and inspections.

Main Responsibilities

  • Supporting the Quality Management System (QMS) by ensuring compliance of departmental procedures to existing and upcoming requirements.
  • Conducting trend analysis on key KPIs to identify improvement initiatives.
  • Participating in the PS API Quality-related networks and coordinating input to the Quality Management Review on behalf of the CVP area.
  • Collaborating in the planning, preparation, and execution of audits and inspections in API Business Support and contributing as a resource during audits and inspections across PS API.
  • Driving Quality improvement initiatives applying PDCA (Plan Do Check Act), systematic problem solving, process mapping, or other LEAN methodologies – including participation in the reduction of deviations.
  • Performing the role as an “Editor” to ensure the correct workflows of Quality documents and driving the yearly planning of Quality activities.

Requirements

To be successful in this role, you will need:

  • A relevant academic degree or a master’s degree, preferably within chemistry, life sciences, or any other relevant field.
  • Over 5 years of experience within GMP and compliance.
  • Excellent communication and collaboration skills, and fluency in English.
  • Possession of a LEAN mindset, curiosity, and some project management skills or experience.

About Us

We strive to be more agile, think bigger, and reduce complexity in the CVP area. We expect you to be the “go-to” person on quality subjects and to be involved in relevant projects to ensure quality is built simultaneously with the development and implementation of new technology.

Salary

Our estimated salary for this role is approximately €65,000 - €80,000 per year, depending on your qualifications and experience.



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