Remote GMP/GDP QA Auditor – Supplier & Compliance

Travere Therapeutics; Columbia (SC); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with employer match

Generous paid time off

Well-being programs

Job summary

Travere Therapeutics, based in San Diego, is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits and supplier oversight within a global partner network. You will collaborate across Technical Operations, Supply Chain, Regulatory Affairs, and other teams to maintain inspection readiness and robust supplier qualification.

The role requires a strong background in FDA/GxP audits, risk assessment, and quality systems, with the ability to travel 25-40% domestically and internationally.

Qualifications

• Requires 5+ years of Quality Assurance experience in FDA-regulated industry.
• Requires 3+ years of GMP/GDP auditing experience.
• Experience auditing pharma/biologic/medical device/GxP service providers.
• Experience with supplier qualification and regulatory inspections.
• Experience with electronic Quality Management Systems; Veeva Vault Quality Suite 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 CAPA plans.
• Track audit findings and quality actions through closure; support metrics & reporting.

Skills

Auditing

Quality Assurance

Regulatory compliance

Supplier qualification

Documentation

Education

Bachelor's degree in Life Sciences or related field

Lead Auditor certification (ASQ/IRCA/Exemplar Global) preferred

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics, based in San Diego, is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits and supplier oversight within a global partner network. You will collaborate across Technical Operations, Supply Chain, Regulatory Affairs, and other teams to maintain inspection readiness and robust supplier qualification.

The role requires a strong background in FDA/GxP audits, risk assessment, and quality systems, with the ability to travel 25-40% domestically and internationally.