Senior QA Auditor – GMP/GDP (Remote-Eligible)

Travere Therapeutics; Detroit (MI); Híbrido; USD 95.000 - 124.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Premium health benefits

Retirement plan with employer match

Generous paid time off

Descripción de la vacante

Travere Therapeutics in San Diego seeks a Senior Quality Assurance Associate to execute GMP/GDP audits and support supplier qualification across our external partner network. You will ensure compliance with FDA/EU/ICH/ISO and maintain readiness for inspections.

The role partners with Quality, Regulatory, and Clinical Operations to drive risk-based auditing, CAPA management, and continuous quality improvement in a fast-paced, collaborative environment.

Formación

• 5+ years of Quality Assurance experience within an FDA-regulated industry.
• 3+ years of GMP and/or GDP auditing experience.
• Experience auditing pharmaceutical, biologic, medical device, and/or GxP service providers.
• Experience with supplier qualification, supplier oversight, and regulatory inspections.
• Lead Auditor certification (ASQ, IRCA, Exemplar Global) preferred.

Responsabilidades

• Execute GMP and GDP audits of contract manufacturers, testing laboratories, distribution providers, and logistics partners.
• Plan, conduct, and document on-site, remote, and hybrid audits.
• Review supplier responses and CAPA plans; track findings to closure.
• Support supplier qualification, oversight, and risk assessments; maintain ASLs.

Conocimientos

Auditing

Quality Assurance

Regulatory compliance

GxP knowledge

Technical writing

Educación

Bachelor's degree in Life Sciences

Herramientas

Veeva Vault Quality Suite

Descripción del empleo

Travere Therapeutics in San Diego seeks a Senior Quality Assurance Associate to execute GMP/GDP audits and support supplier qualification across our external partner network. You will ensure compliance with FDA/EU/ICH/ISO and maintain readiness for inspections.

The role partners with Quality, Regulatory, and Clinical Operations to drive risk-based auditing, CAPA management, and continuous quality improvement in a fast-paced, collaborative environment.