Senior GxP QA Auditor - GMP/GDP & Supplier Oversight

Travere Therapeutics; New York (NY); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Health benefits

Stock options

Paid time off

Job summary

Travere Therapeutics in San Diego, CA seeks a Senior Quality Assurance Associate - GMP/GDP Auditing to lead audits of contract manufacturers, testing labs, and distribution partners, and support supplier qualification and inspection readiness.

You will partner with Technical Operations, Regulatory Affairs, and Quality to maintain GxP compliance, manage CAPAs, and drive continuous improvement across the external partner network.

Qualifications

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

Responsibilities

• Plan, conduct, and document GMP/GDP audits of contract manufacturers, labs, and logistics providers.
• Support supplier qualification, oversight, and ASLs.
• Maintain audit reports, CAPA reviews, and risk assessments.
• Assist in inspection readiness activities and regulatory inspections.
• Use Quality Management System tools (e.g., Veeva Vault) for quality events and actions.

Skills

Audit management

Regulatory knowledge

Technical writing

Travel readiness

Education

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or related field

Tools

Veeva Vault Quality Suite

Job description

Travere Therapeutics in San Diego, CA seeks a Senior Quality Assurance Associate - GMP/GDP Auditing to lead audits of contract manufacturers, testing labs, and distribution partners, and support supplier qualification and inspection readiness.

You will partner with Technical Operations, Regulatory Affairs, and Quality to maintain GxP compliance, manage CAPAs, and drive continuous improvement across the external partner network.