Senior GMP/GDP Auditor – Remote, Supplier Quality

Travere Therapeutics; Des Moines (IA); Hybride; USD 95 000 - 124 000; Plein temps

Résumé du poste

Travere Therapeutics is seeking a Senior Quality Assurance Associate - GMP/GDP Auditing to lead risk-based audits of contract manufacturers, labs, and distribution partners. You will support supplier qualification, compliance oversight, and inspection readiness across our external network in a fast-paced, cross-functional environment.

In this role you will partner with Technical Operations, Regulatory Affairs, Clinical Operations, and Pharmacovigilance; travel 25-40% domestically and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or related field.
• 5+ years of Quality Assurance experience in an FDA-regulated industry.
• 3+ years of GMP/GDP auditing experience.
• Experience auditing pharmaceutical, biologic, or medical device providers.
• Experience with supplier qualification/oversight and regulatory inspections.
• Lead Auditor certification preferred.

Responsabilités

• Conduct GMP/GDP audits of contract manufacturers, labs, and distribution partners.
• Plan, execute, and document on-site, remote, and hybrid audits.
• Assess compliance with FDA, EU, ICH, ISO requirements and prepare reports.
• Review CAPA plans and track findings through closure.
• Support audit metrics, trending, and management reporting.
• Communicate findings to Quality leadership and stakeholders.
• Support supplier qualification and oversight activities.

Connaissances

GMP/GDP auditing

Quality Assurance

Regulatory compliance

Audit programs

Cross-functional collaboration

Formation

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

Outils

Veeva Vault Quality Suite

Description du poste

Travere Therapeutics is seeking a Senior Quality Assurance Associate - GMP/GDP Auditing to lead risk-based audits of contract manufacturers, labs, and distribution partners. You will support supplier qualification, compliance oversight, and inspection readiness across our external network in a fast-paced, cross-functional environment.

In this role you will partner with Technical Operations, Regulatory Affairs, Clinical Operations, and Pharmacovigilance; travel 25-40% domestically and