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Senior QMS Operations & CAPA Lead

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Ardelyx, Inc.
Full Time position
Listed on 2026-10-07
Job specializations:
  • Healthcare
    Data Scientist
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 176000 - 215000 USD Yearly USD 176000.00 215000.00 YEAR
Job Description & How to Apply Below

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

As a Senior QMS Operations & CAPA Lead, you will play an important part at Ardelyx, Inc. in Waltham, MA, United States.

This role, Senior QMS Operations & CAPA Lead at Ardelyx, Inc., could be your next career step.

Are you ready to take on the Senior QMS Operations & CAPA Lead role at Ardelyx, Inc.?

We would love to welcome a new Senior QMS Operations & CAPA Lead to our organisation in Waltham, MA, United States.

Position Requirements
10+ Years work experience
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