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Ardelyx, Inc.

Senior QMS Operations & CAPA Lead

northern, KY

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About this opportunity

Ardelyx, Inc. lists this Senior QMS Operations & CAPA Lead opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Ardelyx, Inc. seeks an Associate Director, QMS Operations to provide strategic oversight of critical Quality Management System processes with accountability for Deviations, CAPA, Product Complaints and Change Control.

This hybrid role requires collaboration across Quality, Manufacturing, Regulatory, and Medical, ensuring risk-based, compliant execution. You will drive continuous improvement, establish governance standards, and harmonize QMS workflows while supporting regulatory inspections and

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