Senior GMP/GDP QA Auditor — Remote & Supplier Oversight

Travere Therapeutics; Providence (RI); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health benefits

Well-being programs

Employer matching retirement

Job summary

Travere Therapeutics in San Diego, CA is seeking a Senior Quality Assurance Associate focused on GMP/GDP auditing across the external partner network. You will conduct risk-based audits of contract manufacturers, labs, and logistics providers, ensuring regulatory compliance and robust supplier qualification.

You'll collaborate with Technical Operations, Regulatory Affairs, and Quality to prepare reports, CAPA reviews, and auditable records, supporting inspection readiness and continuous

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry or Biology or equivalent.
• 5+ years QA experience in an FDA-regulated industry.
• 3+ years GMP/GDP auditing experience; supplier qualification experience preferred.
• Experience auditing pharmaceutical/biologic/medical device providers; knowledge of GxP is required.
• Experience with electronic Quality Management Systems; Veeva Vault Quality Suite preferred.

Responsibilities

• GMP/GDP auditing of contract manufacturers, labs, distributors, and logistics partners.
• Plan, conduct, and document internal/external audits (on-site, remote, hybrid).
• Assess compliance with FDA/EU/ICH/ISO and other regulatory requirements.
• Prepare audit reports, observations, risk assessments, and CAPA follow-up.
• Support supplier qualification, oversight, ASLs, and risk-based decisions.

Skills

Quality Assurance

Auditing

Regulatory knowledge

Communication skills

Attention to detail

Education

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

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics in San Diego, CA is seeking a Senior Quality Assurance Associate focused on GMP/GDP auditing across the external partner network. You will conduct risk-based audits of contract manufacturers, labs, and logistics providers, ensuring regulatory compliance and robust supplier qualification.

You'll collaborate with Technical Operations, Regulatory Affairs, and Quality to prepare reports, CAPA reviews, and auditable records, supporting inspection readiness and continuous