Senior Quality Assurance Specialist

1 month ago


Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance professional to join our team at Novo Nordisk A/S. As a Senior Quality Assurance Specialist, you will play a key role in ensuring the highest quality and safety of our products and for our patients.

Key Responsibilities
  1. Plan, run, and follow up on GMP inspections in close cooperation with the corporate inspection office and manufacturing sites.
  2. Ensure adequate and timely responses to Regulatory Affairs requests and lead Pre-Approval Inspection activities to obtain market access approval.
  3. Develop and coach internal stakeholders in FPM for inspection readiness.
  4. Support FPM areas in internal audits.
  5. Ensure smooth preparation and execution of on-site inspections in cooperation with stakeholders.
Requirements
  1. Master's degree in pharmacy, engineering, science, or similar.
  2. Experience from the pharmaceutical industry, preferably within production or QA.
  3. Experience in participating in GMP inspections from different health authorities.
  4. Flair for stakeholder management and networking at various organisational levels.
  5. Fluency in both English and Danish.
About the Department

The FPM QA area is divided into six QA departments. You will be joining the Department of Local Manufacturing and Support QA, which includes some of our most experienced business partners within LEAN, training, digitalisation, specialists, and QA process managers.

Working at Novo Nordisk

We value our employees for the unique skills they bring to the table and 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. We rely on the joint potential and collaboration of our employees to go further and make a difference in the lives of patients.



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