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QA & Regulatory Compliance Director — NDA Readiness

Job in Madison, Dane County, Wisconsin, 53774, USA
Listing for: Usona Institute
Full Time position
Listed on 2026-11-04
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 180000 - 240000 USD Yearly USD 180000.00 240000.00 YEAR
Job Description & How to Apply Below

Usona Institute, based in Madison, Wisconsin, seeks a Director of Quality Assurance & Compliance to lead NDA readiness, GxP compliance, and a scalable QA function across sponsor, CROs, and sites. This hands-on leader will own the QMS, drive inspection readiness, and partner with Regulatory Affairs to support NDA submissions and FDA interactions.

Travel 15-25% annually for inspections and audits. The role emphasizes building quality infrastructure with integrity, collaboration, and strategic

We are seeking a motivated QA & Regulatory Compliance Director — NDA Readiness to join Usona Institute in Madison, WI, United States.

Are you ready to take on the QA & Regulatory Compliance Director — NDA Readiness role at Usona Institute?

We would love to welcome a new QA & Regulatory Compliance Director — NDA Readiness to our group in Madison, WI, United States.

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