QA & Regulatory Compliance Director — NDA Readiness

Usona Institute; Madison (WI); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Professional development

Job summary

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

Qualifications

• Leadership in QA with NDA/BLA/regulatory submission experience.
• Experience with FDA inspections and sponsor representation.
• Deep knowledge of GxP regulations and QC processes.

Responsibilities

• Own the quality system and regulatory inspection readiness.
• Lead CAPA, deviations, and audit programs across sponsors/CROs.
• Develop and maintain 21 CFR-based SOPs and eQMS governance.
• Collaborate with Regulatory Affairs on NDA submissions and safety reporting.
• Build scalable QA infrastructure to support post-approval activities.

Skills

Regulatory liaison

Quality leadership

GxP compliance

Audits & CAPA

Team building

Vendor oversight

Strategic thinking

Written communication

Education

Bachelor’s degree in life sciences, pharmacy, chemistry, or related field

Tools

eQMS (MasterControl)

eQMS (Veeva)

Job description

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