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

Travere Therapeutics; San Diego (CA); Hybrid; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics in San Diego, CA is seeking a Senior Quality Assurance Associate – GMP/GDP Auditing to ensure supplier qualification and external quality management across our partner network. You will act as QA SME for audits, risk assessments, and compliance with FDA, EU, ICH, ISO standards.

This role partners with Technical Operations, Supply Chain, Regulatory Affairs and more; requires 5+ years QA in FDA-regulated industry and 3+ years GMP/GDP auditing; 25–40% travel; on-site presence

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 required.
• Experience auditing pharmaceutical, biologic, medical device, and/or GxP service providers.
• Lead Auditor certification (ASQ, IRCA, Exemplar Global, or equivalent) preferred.

Responsibilities

• Conduct risk-based GMP and GDP audits of contract manufacturers, testing laboratories, distribution providers, logistics partners, and/or medical device manufacturers.
• Plan, execute, and document on-site, remote, and hybrid interna/external audits.
• Assess compliance with FDA, EU, ICH, ISO and other regulatory requirements.
• Prepare audit reports, observations, and risk assessments.
• Review supplier responses and evaluate CAPA plans.
• Track audit findings and quality actions through closure.
• Support audit scheduling, metrics, and management reporting.
• Communicate significant audit findings to Quality leadership and cross-functional stakeholders.

Skills

GMP/GDP auditing

Quality Assurance

Regulatory knowledge

Technical writing

Communication

Travel willingness

Education

Bachelor's in Life Sciences or related field

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics in San Diego, CA is seeking a Senior Quality Assurance Associate – GMP/GDP Auditing to ensure supplier qualification and external quality management across our partner network. You will act as QA SME for audits, risk assessments, and compliance with FDA, EU, ICH, ISO standards.

This role partners with Technical Operations, Supply Chain, Regulatory Affairs and more; requires 5+ years QA in FDA-regulated industry and 3+ years GMP/GDP auditing; 25–40% travel; on-site presence