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Fresenius Medical Care

Senior cGMP Quality Leader – Pharma, 401(k) & PTO

waltham, MA

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Job description

Fresenius Medical Care seeks a Quality Manager for cGMP Pharmaceutical Products to guide QA leadership across sites, ensuring compliance with 21 CFR parts and ICH guidelines. The role partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and uninterrupted supply of drug products.

The ideal candidate has 10+ years in QA with leadership experience, hands-on FDA inspection expertise, and strong CAPA/Management Review skills.

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Worksite address

waltham, MA, 02254, US

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