GMP Quality Assurance Specialist

2 months ago


Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full time
Job Overview

This is an exciting opportunity to join Novo Nordisk A/S as a Senior GMP Expert, playing a pivotal role in ensuring the highest level of quality and compliance within Product Control and Global Support.

About the Role

The successful candidate will be responsible for managing various quality-related activities across the department, guiding team members, and setting standards anchored in our Quality Management System. This includes leading and coordinating root cause investigations, driving quality improvements, and preparing for future audits and inspections.

In this position, you will have a high level of independence, guiding and teaching the department, colleagues, and management.

Responsibilities
  • Ensure a high-level GMP overview, reporting quality trends to management, supporting daily QC operations, identifying improvements, and ensuring continued compliance.
  • Lead and coordinate root cause investigations for potential quality and compliance issues across both the department and the functional area.
  • Drive and implement quality improvements within the department.
  • Lead and participate in preparation and follow-up on authority inspections and internal audits.
  • Handle deviations, investigations, quality processes, advise department members on questions and challenges.
Requirements
  • Hold a master's degree in pharmacy, biochemistry, production engineering or similar with practical experience in the pharmaceutical industry with GMP.
  • Possess a strong understanding of GMP regulations and requirements.
  • Have practical experience with investigations, inspections, and deviations, along with a solid LEAN mindset and experience in using LEAN tools.
  • Demonstrate strong stakeholder management skills, setting direction and guiding/coaching.
  • Showcase professional proficiency in both spoken and written English.
About the Department

You will be part of DMD, Product Control & Global Support, where we assist device development from the early R&D development stages into production for clinical trials and eventually into production to market.

Reporting to the Senior Manager of Projects and Product Control Development, you will be a member of a diverse team of highly skilled professionals, Specialists, and Project managers who also work across the department and the organisation.

As a high-potential collaborator in our department, you will embrace significant responsibility and receive guidance to foster your personal and professional growth.

About the Salary

The estimated salary range for this position is between 110000 and 140000 per year, depending on qualifications and experience.

About Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We are inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.



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