Head of Quality Assurance & Regulatory Compliance

Usona Institute; Madison (WI); Presencial; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive health insurance

401(k) retirement plan with employer match

Professional development support

Descripción de la vacante

Usona Institute is seeking a Director, Quality Assurance & Compliance in Madison, Wisconsin. The role involves leading the quality system during Usona's transition to commercial drug development, ensuring rigorous compliance with FDA regulations and overseeing inspection readiness. Ideal candidates will have over 10 years of QA experience in the pharmaceutical sector and strong leadership skills. The position requires a Bachelor's degree in life sciences, with an advanced degree preferred. The role is onsite with potential travel for inspections and audits.

Formación

• Minimum 10 years in pharmaceutical quality assurance.
• At least 5 years in a leadership role.
• Experience with NDA submissions in a QA capacity.

Responsabilidades

• Lead quality assurance for NDA quality submissions.
• Ensure compliance with GxP regulations.
• Manage IND annual reports and safety reporting.

Conocimientos

Leadership

Quality Management Systems (QMS)

Regulatory Compliance

GxP Knowledge

Document Control

Technical Writing

Educación

Bachelor’s degree in life sciences

Advanced degree preferred

Herramientas

eQMS platforms (MasterControl, Veeva)

Descripción del empleo

Usona Institute is seeking a Director, Quality Assurance & Compliance in Madison, Wisconsin. The role involves leading the quality system during Usona's transition to commercial drug development, ensuring rigorous compliance with FDA regulations and overseeing inspection readiness. Ideal candidates will have over 10 years of QA experience in the pharmaceutical sector and strong leadership skills. The position requires a Bachelor's degree in life sciences, with an advanced degree preferred. The role is onsite with potential travel for inspections and audits.