Remote QA Analytics & Validation Lead

Travere Therapeutics; Detroit (MI); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego (remote-friendly, hybrid) seeks an Associate Director, Quality Assurance - Technical. Lead GxP analytical QA, oversee method qualification/validation, and interact with global teams and vendors to ensure compliant testing for clinical and commercial use.

You will provide SME input on risk, support stability and regulatory submissions, and stay current with FDA/ICH/EMA/USP standards while aiding audits and inspections. Travel up to 10–20% may be required.

Qualifications

• 8+ years in analytical functions supporting drug development and commercialization.
• Direct GMP QA, analytical qualification/validation and quality systems experience.
• Broad knowledge of CFR/ICH cGMPs and related international regulations.
• Bachelor's degree required; life science field preferred.

Responsibilities

• Lead analytical qualification, validation and transfer of methods.
• Review and oversee validation activities (protocols, raw data, reports).
• Primary contact for analytical questions and issue resolution with vendors.
• Provide risk assessment input and mitigation recommendations.
• Support stability program with protocol/data review and final reports.
• Assist regulatory submissions and regulatory knowledge updates.

Skills

Analytical QA

Cross-functional collaboration

Regulatory knowledge

GxP compliance

Communication

Education

Bachelor's degree in life science

Job description

Travere Therapeutics in San Diego (remote-friendly, hybrid) seeks an Associate Director, Quality Assurance - Technical. Lead GxP analytical QA, oversee method qualification/validation, and interact with global teams and vendors to ensure compliant testing for clinical and commercial use.

You will provide SME input on risk, support stability and regulatory submissions, and stay current with FDA/ICH/EMA/USP standards while aiding audits and inspections. Travel up to 10–20% may be required.