Senior Quality Assurance Manager for Late Phase Development Projects
4 days ago
We are seeking an experienced Senior Quality Assurance Manager to oversee quality oversight and risk assessment for development projects approaching launch and life cycle management activities.
In this role, you will ensure quality oversight and representation 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, 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:- 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
You will encounter a broad spectrum of stimulating challenges that have garnered senior management's attention, contributing to your personal and professional growth.
RequirementsTo 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.
We offer a competitive salary, estimated at around $120,000 per annum, depending on experience, plus a range of benefits including health insurance, retirement savings plan, and paid time off.
About Novo Nordisk A/S
Novo Nordisk is a global healthcare company with a strong commitment to innovation and patient care. We are passionate about improving the lives of people affected by diabetes and other serious chronic diseases.
Contact Us
If you are a motivated and experienced professional looking to make a difference in the pharmaceutical industry, please submit your application.
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