Director, QA Analytics & Compliance

Travere Therapeutics; Boston (MA); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to lead GxP analytical quality activities and oversight. You will collaborate with cross-functional teams and contract vendors to test products for clinical and commercial use.

The role requires extensive GMP QA experience, analytical qualification/validation, and regulatory knowledge across CFR/ICH and international guidelines, with travel up to 10–20%.

Qualifications

• Bachelor's degree in life sciences; chemistry/biology/chemical engineering preferred.
• 8+ years in analytical roles supporting drug/biologics development.
• Direct GMP QA experience and quality systems familiarity.
• Broad knowledge of CFR/ICH and international regulations.

Responsibilities

• Lead analytical qualification, validation and transfer of analytical methods for small and large molecules.
• Review and oversee analytical validation activities (validation protocol, raw data review, test methods).
• Serve as primary contact for cross-functional groups and vendors for deviations, OOS/OOT results, change controls, CAPA.
• Provide SME input for risk assessments and mitigation recommendations.

Skills

GxP Compliance

Analytical Method Validation

Quality Systems

Cross-functional Collaboration

Regulatory Knowledge

Education

Bachelor's degree in life sciences

8+ years in analytical/QA roles

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to lead GxP analytical quality activities and oversight. You will collaborate with cross-functional teams and contract vendors to test products for clinical and commercial use.

The role requires extensive GMP QA experience, analytical qualification/validation, and regulatory knowledge across CFR/ICH and international guidelines, with travel up to 10–20%.