QA Specialist for Product Development Projects
2 weeks ago
QA Specialist for Product Development Projects
Category: Quality
Location: Høje-Taastrup, Capital Region of Denmark, DK
Are you eager to leverage your robust quality mindset and scientific background within QA and GMP to set a clear quality direction for Novo Nordisk late phase development projects? Do you aspire to apply your project management skills while playing a pivotal role in ensuring the quality and safety of new Novo Nordisk products? If you are ready to bring your strategic expertise to the forefront, then we have the perfect opportunity for you, read more and apply now
The Position
In this role, you will ensure quality oversight for new products, serving as the central QA in strategic project teams. Your responsibilities include setting a 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.
Main responsibilities for this role will be to:
- Ensure quality oversight and risk assessment 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
As a Senior QA Project Manager, you will encounter a broad spectrum of stimulating challenges that have garnered senior management's attention, contributing to your personal and professional growth.
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 several years' solid experience in the drug-oriented fields such as drug substance, drug product, QA or production within the pharmaceutical industry
- Have in-depth or specialist experience with GMP guidelines and regulations
- Have experience in process technical transfer and/or validation, underscoring expertise in critical areas
- Have full English proficiency
It will be seen as an advantage if you have covered project management roles, and at least familiarity with project based work will be required.
On a personal level, you demonstrate adept collaboration, communication, and project management skills, highlighting the ability to drive successful outcomes and contribute to solving complex challenges.
Furthermore, you exhibit a high level of independence, personal engagement, and drive, reflecting commitment to achieving high-quality outcomes.
About the department
Product Development (PD) QA is a new area in Product Supply Quality and IT (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 located both in Denmark and our international production sites. Our working style is flexible, dynamic, and informal with a strong culture of cross-functional collaboration, where your contributions will be valuable and make a difference.
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
Deadline
12 January 2025
You do not need to attach a cover letter to your application, but we encourage you to include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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.
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