Senior QA Auditor - GMP/GDP (Remote)

Travere Therapeutics; Manchester (NH); Hybride; USD 95 000 - 124 000; Plein temps

Avantages offerts par ce poste

Premium health benefits

Financial & retirement plans

Generous paid time off

Life Insurance

Disability coverage

Résumé du poste

Travere Therapeutics in San Diego, CA, seeks a Senior Quality Assurance Associate - GMP/GDP Auditing to execute audits, support supplier qualification, and drive inspection readiness across our external partner network.

This role partners with Technical Operations, Supply Chain, Regulatory Affairs, and Clinical Operations to maintain robust supplier programs and support regulatory inspections; travel 25-40% domestically and internationally.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or a related scientific discipline required.
• 5+ years of Quality Assurance experience within an FDA-regulated industry required.
• 3+ years of GMP and/or GDP auditing experience.
• Experience auditing pharmaceutical, biologic, medical device, and/or GxP service providers.
• Experience with supplier qualification, supplier oversight, and regulatory inspections.
• Lead Auditor certification (ASQ, IRCA, Exemplar Global, or equivalent) preferred.

Responsabilités

• Conduct risk-based GMP and GDP audits of contract manufacturers, testing laboratories, distribution providers, logistics partners, and/or medical device manufacturers.
• Plan, execute, and document on-site, remote, and hybrid interna/external audits.
• Assess compliance with applicable FDA, EU, ICH, ISO, and other regulatory requirements.
• Prepare audit reports, observations, and risk assessments.
• Review supplier responses and evaluate CAPA plans.
• Track audit findings and quality actions through closure.
• Support audit schedule preparation, audit metrics, trending, and management reporting.
• Communicate significant audit findings and compliance risks to Quality leadership and stakeholders.

Connaissances

Auditing expertise

Regulatory knowledge

Technical writing

Communication

Organizational skills

Formation

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

Outils

Veeva Vault Quality Suite

Description du poste

Travere Therapeutics in San Diego, CA, seeks a Senior Quality Assurance Associate - GMP/GDP Auditing to execute audits, support supplier qualification, and drive inspection readiness across our external partner network.

This role partners with Technical Operations, Supply Chain, Regulatory Affairs, and Clinical Operations to maintain robust supplier programs and support regulatory inspections; travel 25-40% domestically and internationally.