Senior QA Auditor (GMP/GDP) – Remote

Travere Therapeutics; Oklahoma City (OK); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Health benefits

Job summary

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP and GDP audits across external partners. You will support supplier qualification, compliance oversight, and inspection readiness within a global partner network.

You will collaborate with Technical Operations, Supply Chain, Regulatory Affairs and Clinical Operations to ensure regulatory compliance and product quality for rare disease therapies. Travel 25-40% worldwide.

Qualifications

• Bachelor's degree in Life Sciences or related field required, combination with experience considered.
• 5+ years QA experience in FDA-regulated industry required.
• 3+ years GMP/GDP auditing experience.
• Experience auditing pharma/biotech/medical device/GxP providers.
• Experience with supplier qualification and regulatory inspections.
• Veeva Vault Quality Suite experience preferred; Lead Auditor certification preferred.

Responsibilities

• Execute GMP and GDP audits across contract manufacturers and labs.
• Plan, perform, and document on-site, remote and hybrid audits.
• Assess compliance with FDA, EU, ICH, ISO and other regs.
• Prepare reports, observations, risk assessments and CAPA reviews.
• Manage audit findings and close quality actions.
• Support supplier qualification and qualification records maintenance.
• Participate in inspections and due diligence activities.

Skills

GMP/GDP auditing

Regulatory compliance

Vendor qualification

Quality systems

Lead Auditor (preferred)

Communication skills

Travel readiness

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics is seeking a Senior Quality Assurance Associate to lead GMP and GDP audits across external partners. You will support supplier qualification, compliance oversight, and inspection readiness within a global partner network.

You will collaborate with Technical Operations, Supply Chain, Regulatory Affairs and Clinical Operations to ensure regulatory compliance and product quality for rare disease therapies. Travel 25-40% worldwide.