Senior QA Auditor – GMP/GDP & Supplier Oversight (Remote)

Travere Therapeutics; Minneapolis (MN); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health benefits

Well-being programs

Job summary

Travere Therapeutics in San Diego is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits of contract manufacturers and suppliers, ensuring compliance with FDA, EU, and ICH standards.

You will collaborate with cross-functional teams on supplier qualification, audit readiness, and continuous improvement; travel 25-40% domestically and internationally. A Life Sciences degree and 5+ years QA with auditing are required.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or a related scientific discipline required.
• 5+ years of Quality Assurance experience within an FDA-regulated industry required.
• 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.
• Experience with electronic Quality Management Systems; Veeva Vault Quality Suite preferred.
• Lead Auditor certification (ASQ, IRCA, Exemplar Global, or equivalent) preferred.

Responsibilities

• Execute GMP and GDP audits; support supplier qualification and audit program readiness.
• Plan, perform, and document on-site, remote, and hybrid audits.
• Review supplier responses and CAPA plans; track findings to closure.
• Support audit metrics, trending, and management reporting.

Skills

Quality Assurance

GxP auditing

Regulatory compliance

Vendor management

Technical writing

Education

Bachelor's degree in Life Sciences

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics in San Diego is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits of contract manufacturers and suppliers, ensuring compliance with FDA, EU, and ICH standards.

You will collaborate with cross-functional teams on supplier qualification, audit readiness, and continuous improvement; travel 25-40% domestically and internationally. A Life Sciences degree and 5+ years QA with auditing are required.