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Senior Hybrid IT Compliance & Validation Lead; GxP​/FDA

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: ardelyx
Full Time position
Listed on 2026-07-21
Job specializations:
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 145000 - 177000 USD Yearly USD 145000.00 177000.00 YEAR
Job Description & How to Apply Below
Position: Senior Hybrid IT Compliance & Validation Lead (GxP/FDA)

Ardelyx is seeking a Senior Quality Information Systems Specialist to support IT compliance, risk management, and computer systems validation in a regulated life sciences environment. You will work with cross-functional teams to ensure audits readiness and validate enterprise applications, with a hybrid work arrangement in Waltham, MA or Newark, CA.

The role focuses on change management, lifecycle activities, and addressing CAPAs within GxP and FDA requirements, collaborating with Quality

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Position Requirements
10+ Years work experience
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