Senior cGMP Quality Manager — FDA-Inspections Ready
Fresenius Medical Care
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Benefits offered by this job
Job summary
Fresenius Medical Care is seeking a Quality Manager, cGMP Pharmaceutical Products, to provide strategic and operational QA leadership across multiple sites. You will partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to ensure compliant drug product manufacturing and uninterrupted supply.
The role requires extensive experience in QA leadership, FDA inspections, and deep knowledge of cGMP and ICH guidelines.
Qualifications
- Bachelor's degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline.
- Master's degree or advanced technical degree preferred.
Responsibilities
- Oversee QA responsibilities at pharma/drug sites and ensure compliance with cGMP.
- Lead CAPA management, validation, regulatory inspections, and management reviews.
- Partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality.
- Prepare for FDA inspections and respond to 483 observations in collaboration with Regulatory Affairs.
- Drive continuous improvement and resource allocation decisions based on data trends.
Skills
Education
Tools
Job description
Fresenius Medical Care is seeking a Quality Manager, cGMP Pharmaceutical Products, to provide strategic and operational QA leadership across multiple sites. You will partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to ensure compliant drug product manufacturing and uninterrupted supply.
The role requires extensive experience in QA leadership, FDA inspections, and deep knowledge of cGMP and ICH guidelines.
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