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

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

Job summary

Travere Therapeutics seeks a Senior Quality Assurance Associate to lead GMP/GDP audits and supplier oversight across our external partner network. You will ensure compliance with FDA/EU/ICH/ISO standards and support CAPA reviews and audit reporting.

Collaborate with Technical Operations, Supply Chain, Regulatory Affairs, and Clinical Operations, with travel up to 25-40% domestically and internationally. Stay audit-ready and drive continuous improvement in quality systems.

Qualifications

• Bachelor's degree in Life Sciences or related field required/considered with experience.
• 5+ years QA experience in FDA-regulated industry.
• 3+ years GMP/GDP auditing experience.

Responsibilities

• Plan, conduct, and document GMP/GDP audits of suppliers and partners.
• Support supplier qualification, risk assessments and ASLs.
• Assist in inspection readiness and regulatory inspections.

Skills

Technical writing

Communication skills

Regulatory knowledge

Audit leadership

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics seeks a Senior Quality Assurance Associate to lead GMP/GDP audits and supplier oversight across our external partner network. You will ensure compliance with FDA/EU/ICH/ISO standards and support CAPA reviews and audit reporting.

Collaborate with Technical Operations, Supply Chain, Regulatory Affairs, and Clinical Operations, with travel up to 25-40% domestically and internationally. Stay audit-ready and drive continuous improvement in quality systems.