Director, QA & Compliance — NDA Readiness Leader

Promega; Madison (WI); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Comprehensive health insurance

401(k) retirement plan with employer match

Professional development support

Flexible approach to schedules

Job summary

Usona Institute in Madison, Wisconsin, is seeking a Director of Quality Assurance & Compliance. This role is pivotal in the transition from clinical trial sponsorship to commercial drug development. The ideal candidate will have at least 10 years of experience in pharmaceutical quality assurance, with 5 years in leadership. Responsibilities include overseeing quality systems, ensuring FDA compliance, and readiness for inspections. The position offers competitive compensation, comprehensive health benefits, and a commitment to work-life balance.

Qualifications

• Minimum 10 years of progressive experience in pharmaceutical quality assurance.
• At least 5 years in a leadership role.
• Experience supporting NDA, BLA, or equivalent regulatory submissions.

Responsibilities

• Own the quality system and lead inspection readiness.
• Serve as the senior quality leader for Usona.
• Ensure compliance with FDA regulations.

Skills

Pharmaceutical quality assurance

Regulatory compliance

Leadership

GxP regulations

Collaboration

Education

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

Advanced degree preferred

Tools

eQMS (ETQ, MasterControl, Veeva)

Job description

Usona Institute in Madison, Wisconsin, is seeking a Director of Quality Assurance & Compliance. This role is pivotal in the transition from clinical trial sponsorship to commercial drug development. The ideal candidate will have at least 10 years of experience in pharmaceutical quality assurance, with 5 years in leadership. Responsibilities include overseeing quality systems, ensuring FDA compliance, and readiness for inspections. The position offers competitive compensation, comprehensive health benefits, and a commitment to work-life balance.