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Provide GMP/GDP expertise and supervise the clinical trials supplies within the EU and Switzerland and ensure the correct handling of the IMP (Investigational Medicinal Product)...
The Head of Quality Operations is responsible for leading Amicus’ Quality Operations Team, ensuring a robust GMP Quality System and compliance of our Internal and External GMP...
You will provide leadership and QA expertise to manage the lifecycle of products available on the market including submissions, launches, product improvements, and phase-outs. You...
Lead, manage, and develop multiple laboratory teams, fostering a culture of excellence and continuous improvement. Oversee protein analytical methods, including method development...
You will be responsible for a wide range of activities related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. You will...
You will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial...
You act as primary quality contact for the assigned product for both internal and external stakeholders in an international and very dynamic work environment from development until...
The primary focus of this job is to lead and guide the late stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services at...
Lead and manage QA EU & international (RoW excl North America) consisting of QA Supplier managers, ensuring compliance with GMP/GDP regulations; Responsible for a robust and...
In this role you will be leading an experienced team of analysts and senior analysts in the Quality Control department. This will involve planning against operational and supply...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan...