Senior GMP/GDP QA Auditor — Remote, Global Supplier Audits

Travere Therapeutics; Columbus (OH); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health

Retirement plans with match

Paid time off

Well-being programs

Life insurance

Job summary

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits across the external partner network, ensuring FDA/EU compliance and robust supplier qualification. The role partners with multiple cross-functional teams to maintain inspection readiness and drive continuous improvement.

The ideal candidate has 5+ years QA experience in FDA-regulated environments, 3+ years GMP/GDP auditing, and experience with Veeva Vault Quality Suite or similar eQMS.

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

• GMP/GDP Auditing: 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 schedule preparation, audit metrics, trending, and management reporting.
• Communicate significant audit findings and compliance risks to Quality leadership and stakeholders.

Skills

Quality Assurance

Auditing

Regulatory knowledge

Written communication

Education

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

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP/GDP audits across the external partner network, ensuring FDA/EU compliance and robust supplier qualification. The role partners with multiple cross-functional teams to maintain inspection readiness and drive continuous improvement.

The ideal candidate has 5+ years QA experience in FDA-regulated environments, 3+ years GMP/GDP auditing, and experience with Veeva Vault Quality Suite or similar eQMS.