Senior QA Auditor (GMP/GDP) – Remote

Regulatory Jobs; San Diego (CA); Presencial; USD 95.000 - 124.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Premium health benefits

401(k) with employer match

Generous paid time off

Descripción de la vacante

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits and supplier oversight. You will work across Quality, Regulatory, and Ops teams to ensure compliance with FDA/EU regulations and company standards.

The role requires 5+ years in QA within FDA-regulated industries and 3+ years auditing GMP/GDP. Travel 25–40% is expected; on-site with some remote work in a global supply network.

Formación

• 5+ years of Quality Assurance in FDA-regulated industry.
• 3+ years GMP/GDP auditing experience.
• Experience with supplier qualification and regulatory inspections.

Responsabilidades

• Execute GMP and GDP audits of CMOs, labs, distributors, and device manufacturers.
• Plan and document on-site, remote, and hybrid audits; assess regulatory compliance.
• Prepare reports, CAPA reviews, and risk assessments; track closure.
• Support supplier qualification, oversight, and ASL maintenance.
• Assist in quality systems, inspections readiness, and continuous improvement.

Conocimientos

Quality Assurance

Audit management

Regulatory compliance

Cross-functional collaboration

Risk assessment

Educación

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology

Lead Auditor certification (preferred)

Herramientas

Veeva Vault Quality Suite

eQMS

Descripción del empleo

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits and supplier oversight. You will work across Quality, Regulatory, and Ops teams to ensure compliance with FDA/EU regulations and company standards.

The role requires 5+ years in QA within FDA-regulated industries and 3+ years auditing GMP/GDP. Travel 25–40% is expected; on-site with some remote work in a global supply network.