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UDLØBET

Novo Nordisk

Senior QA Project Manager for Product Development

Fuldtid

Permanent

Gladsaxe

SE PÅ KORT
ID: 2638685
|
Indrykket for 116 dage siden

Are you looking for an exciting opportunity to use your strong quality mindset and scientific background within QA and GMP to set a clear quality direction in Novo Nordisk? Do you aspire to leverage your project management skills while playing a pivotal role in ensuring the quality and safety of new Novo Nordisk products? 

If yes, then we have the right position for you in our newly formed ‘Development Product Portfolio QA’ (DPP QA). We are expanding and seeking new colleagues with relevant QA experience and knowledge across different pharmaceutical areas to join a team of QA Project Managers all responsible for their projects and products. 


The Position

You can look forward to a broad range of exciting challenges that have senior management's attention feeding into your personal and professional development. As a senior QA PM, you will ensure quality oversight for new products, serving as the central QA in strategic project teams. Your responsibilities include setting clear quality direction across the entire value chain, representing QA and ensuring quality oversight from the late product development phase into the life cycle management across diverse therapeutic areas such as Diabetes, Obesity and Rare Diseases. 

As our new Senior QA Project Manager (QA PM), you will:

  • Ensure quality oversight for development projects approaching launch and life cycle management activities.
  • Plan, coordinate, and track QA project activities in collaboration with relevant area QAs.
  • Integrate quality aspects into project strategies, development plans and validation strategies.
  • Proactively address potential quality drift in development projects.
  • Contribute to and endorse project strategies.

  • Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration, where your contributions will be valuable and make a difference. 


    Qualifications

    To succeed in this role, you should:

  • Hold a Master's or PhD degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar. 
  • Have at least 5 years of solid experience preferably within Novo Nordisk or other pharmaceutical company.
  • Demonstrate experience in QA and Project Management within drug development and life cycle management (LCM) projects in GMP regulated environments. 
  • Proficiency in English in both written and spoken.
  • As a person, you possess an in-depth understanding of GMP regulations, requirements, and guidelines for pharmaceutical development and production. Your experience in process technical transfer and/or process validation demonstrates your expertise in critical areas. Your excellent collaboration and communication skills, along with strong project management abilities, showcase your capacity to drive successful outcomes. 

    You have a proven ability to set a clear quality direction, contribute to solving complex challenges, and establish quality oversight about business strategies and project scope. Furthermore, your high level of independence, personal engagement, and drive reflect your commitment to achieving high-quality outcomes.

    About the department

    Product Development (PD) QA is a new area in PSQIT 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.

    DPP QA consists of approximately 25 highly skilled employees. You will become part of a department with many interfaces across the organization across Denmark and our international production sites. 
    We work towards continuously improving our competences, as well as making work processes more efficient and effective. 

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