GMP/GDP QA Auditor & Supplier Oversight Specialist

Travere Therapeutics; Wichita (KS); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health

Employer 401(k) match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior Quality Assurance Associate in San Diego to lead GMP/GDP audits of external partners and support supplier qualification and ongoing quality oversight. You will collaborate with cross-functional teams to ensure regulatory compliance and audit readiness.

Responsibilities include coordinating on-site, remote, and hybrid audits, reviewing CAPAs, and maintaining supplier qualifications.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 5+ years of Quality Assurance experience in FDA-regulated industry.
• 3+ years of GMP and/or GDP auditing experience.
• Experience auditing pharmaceutical, biologic, medical device, and/or GxP service providers.

Responsibilities

• Conduct GMP/GDP audits of contract manufacturers, testing laboratories, distribution providers, and logistics partners.
• Plan and document onsite, remote, and hybrid audits.
• Review supplier responses and CAPA plans; track findings to closure.
• Support supplier qualification, oversight, and regulatory inspections.

Skills

GMP/GDP knowledge

Technical writing

Communication skills

Organizational skills

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 in San Diego to lead GMP/GDP audits of external partners and support supplier qualification and ongoing quality oversight. You will collaborate with cross-functional teams to ensure regulatory compliance and audit readiness.

Responsibilities include coordinating on-site, remote, and hybrid audits, reviewing CAPAs, and maintaining supplier qualifications.