Senior QA Project Manager for Product Development (Denmark, Høje-Taastrup)

Jobbeskrivelse
Placering
Høje-Taastrup, Denmark

Jobkategori
Project Management & Agile

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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 key 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 the attention of senior management and support your personal and professional development. As a senior QA Project Manager (QA PM), you will ensure quality oversight for development 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 early to late phase clinical development across diverse therapeutic areas such as Diabetes, Obesity and Rare Diseases.

As our new Senior QA PM, you will:

• Ensure quality oversight for development projects approaching first human dose and throughout the development towards launch.
• Plan, coordinate, and track QA project activities in collaboration with relevant operational QA departments.
• Act as QA Outsourcing Manager for externally produced development products being the QA contact to Contract Manufacturing Organizations (CMO)
• Integrate quality aspects into project strategies and development plans.
• 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. The primary work location is in Høje Taastrup, but there is also the option to work from other sites within the Copenhagen area on certain days.

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
• Experience from working with CMO’s 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 development 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.

Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we 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. Novo Nordisk relies on the joint potential and collaboration of its more than 60,000 employees. Together, we go further. Together, we’re life changing.

Contact
For further information, please contact Director Tenna Aggerholm Møller at +45 3448 7725.

Deadline
24 November 2024.

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.