Quality Management System Partner

1 month ago

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

We are seeking a highly skilled Quality Management System Partner to join our team at Novo Nordisk A/S. As a key member of our CMC Development & Scaling department, you will play a critical role in ensuring the highest level of quality and compliance in our operations.

Key Responsibilities
  • Ensure high-level GMP overview and report quality trends to management.
  • Drive preparation for, participate in, and follow-up on authority inspections and internal audits.
  • Responsible for the Quality Management Review (QMR).
  • Support daily operations and ensure the relevant level of GMP and training.
  • Be the go-to person on quality subjects; actively identify and drive quality improvement initiatives, and support as needed by applying systematic problem-solving, process mapping, or other LEAN methodologies.
Requirements
  • Master's degree in pharmacy, biochemistry, production engineering, or similar.
  • At least 5 years of GMP experience from the pharmaceutical industry (manufacturing/QC/QA).
  • Strong understanding of GMP regulations and requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work independently with a pragmatic mindset.
  • Experience with project management.
  • Preferably cLEAN certified.
  • Ability to manage multiple projects and priorities.
  • Full professional proficiency in English, Danish is an advantage, but not required.
About the Department

As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for clinical trials and have a strong culture with a 'can do' mind-set. CMC Drug Product and Analytical Development (DP & Ana Dev), we turn molecules from early research into approvable products ready for the market. In DP & Ana Dev, we develop, document, and supply drug products, manufacturing processes, analytical methods, and analytical results. We are an ambitious organization with a strong culture. We constantly challenge and question the existing processes and identify new opportunities to solve problems. We do our best to deliver despite any obstacles along the way.

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