Senior QA Auditor: GMP/GDP | Remote & Global Supplier Focus

Travere Therapeutics; Boston (MA); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego, CA, is seeking a Senior Quality Assurance Associate for GMP/GDP auditing. You will conduct risk-based audits of external partners, support supplier qualification, and ensure compliance with FDA, EU, ICH, and ISO standards.

You will collaborate with cross-functional teams to maintain inspection readiness and drive continuous quality improvement across the supplier network.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or related discipline required.

Responsibilities

• Conduct GMP and GDP audits of contract manufacturers, labs, distributors, and devices.
• Plan, execute, and document on-site, remote, and hybrid audits.
• Review CAPA and audit responses and track close-out of findings.
• Support supplier qualification, oversight, and regulatory inspections.

Skills

Quality Assurance

Auditing

GxP Audits

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics in San Diego, CA, is seeking a Senior Quality Assurance Associate for GMP/GDP auditing. You will conduct risk-based audits of external partners, support supplier qualification, and ensure compliance with FDA, EU, ICH, and ISO standards.

You will collaborate with cross-functional teams to maintain inspection readiness and drive continuous quality improvement across the supplier network.