Senior Quality Assurance Specialist
3 days ago
About the Role
">As a Senior QA Project Manager at Novo Nordisk, you will play a pivotal role in ensuring the quality and safety of new products. You will be responsible for setting a clear quality direction across the entire value chain, representing QA, and ensuring quality oversight from late product development into life cycle management.
">Main responsibilities include:
">- Ensuring quality oversight and risk assessment for development projects approaching launch and life cycle management activities
- Planning, coordinating, and tracking QA project activities in collaboration with relevant area QAs
- Integrating quality aspects into project strategies, development plans, and validation strategies
- Proactively addressing potential quality drift in development projects
- Contributing to and endorsing project strategies
You will encounter a broad spectrum of stimulating challenges that have garnered senior management's attention, contributing to your personal and professional growth.
">About Your 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. You should also have several years' solid experience in the drug-oriented fields such as drug substance, drug product, QA, or production within the pharmaceutical industry.
">Additionally, you should have in-depth or specialist experience with GMP guidelines and regulations, as well as experience in process technical transfer and/or validation, underscoring expertise in critical areas.
">Full English proficiency is required, and familiarity with project-based work is essential. A high level of independence, personal engagement, and drive, reflecting commitment to achieving high-quality outcomes, are highly valued.
">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). This team 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.
">This dynamic and informal working style values cross-functional collaboration, where your contributions will be valuable and make a difference.
">About Working at Novo Nordisk
">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. This can only be achieved with talented employees with diverse perspectives, backgrounds, and cultures.
">We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in.
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