Senior QA Auditor GMP/GDP - Remote & Global Impact

Travere Therapeutics; Atlanta (GA); Híbrido; USD 95.000 - 124.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Premium health benefits

Stock options

Paid time off

Descripción de la vacante

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits across the external partner network. You will partner with Technical Operations, Supply Chain, Regulatory Affairs, and Clinical Ops to ensure supplier qualification and audit program excellence.

The role covers on-site, remote, and hybrid audits, with travel up to 25-40%. A strong background in FDA-regulated quality systems and risk-based auditing is essential.

Formación

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry or Biology required or equivalent.
• 5+ years QA experience in FDA-regulated industry.
• 3+ years GMP/GDP auditing experience.
• Experience auditing pharma/biologic/medical device providers.
• Experience with supplier qualification, oversight, and inspections.
• Experience with electronic QMS; Veeva Vault Quality Suite preferred.
• Lead Auditor certification preferred.

Responsabilidades

• Conduct GMP/GDP audits of contract manufacturers, labs, and distributors.
• Plan, execute, and document on-site, remote, and hybrid audits.
• Assess compliance with FDA/EU/ICH/ISO requirements.
• Prepare audit reports, observations, and risk assessments.
• Review CAPAs and track closing of findings.
• Support audit schedules, metrics, and management reporting.
• Escalate significant risks to Quality leadership.

Conocimientos

Quality Assurance

GMP/GDP auditing

Regulatory knowledge

Technical writing

Communication

Prioritization

Educación

Bachelor's degree in Life Sciences or related

Herramientas

Veeva Vault Quality Suite

Descripción del empleo

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits across the external partner network. You will partner with Technical Operations, Supply Chain, Regulatory Affairs, and Clinical Ops to ensure supplier qualification and audit program excellence.

The role covers on-site, remote, and hybrid audits, with travel up to 25-40%. A strong background in FDA-regulated quality systems and risk-based auditing is essential.