Senior Quality Manager for Late Phase Development Projects

1 day ago


Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

About the Role

Novo Nordisk A/S is seeking a Senior Quality Manager to ensure quality oversight for new products, serving as the central QA in strategic project teams. The ideal candidate will have a strong background in QA and GMP, with experience in process technical transfer and/or validation.

Main Responsibilities

  1. Quality Oversight: Ensure quality oversight and risk assessment for development projects approaching launch and life cycle management activities.
  2. QA Project Activities: Plan, coordinate, and track QA project activities in collaboration with relevant area QAs.
  3. Integration of Quality Aspects: Integrate quality aspects into project strategies, development plans, and validation strategies.
  4. Addressing Potential Quality Drift: Proactively address potential quality drift in development projects.
  5. Contributing to Project Strategies: Contribute to and endorse project strategies.

Key Qualifications

  • A master's or PhD degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar.
  • Solid experience in the drug-oriented fields such as drug substance, drug product, QA or production within the pharmaceutical industry.
  • In-depth or specialist experience with GMP guidelines and regulations.
  • Experience in process technical transfer and/or validation, underscoring expertise in critical areas.
  • Full English proficiency.

About the Department

The Product Development (PD) QA department is a new area established to gather all QA responsibilities for the Development Product Portfolio (DPP). The new organization will act as a QA single point of entry into PSQIT providing an end-to-end quality overview, ensuring the quality strategy for commercial scalability and manufacturability from early development to life cycle management.

Working at Novo Nordisk A/S

Novo Nordisk A/S is a company that values its employees for the unique skills they bring to the table. We work continuously to bring out the best in them. Working at Novo Nordisk A/S is working toward something bigger than ourselves, and it's a collective effort.



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