Analytical QA Director — Remote

Travere Therapeutics; Kansas City (MO); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Quality Assurance - Technical to lead GxP analytical quality support and oversight for clinical and commercial testing. You will collaborate with cross‑functional teams and vendors to ensure analytical method validation, data integrity and regulatory compliance.

Responsibilities include leading qualification/validation/transfer of QC methods, managing deviations, CAPAs, change controls, and support for regulatory

Qualifications

• Bachelor's degree in life sciences or related field required.
• 8+ years in an analytical function supporting drug/biologics development and commercialization in biotech/pharma.
• Direct GMP Quality Assurance experience with Analytical Qualification/Validation and Quality Systems.
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations.

Responsibilities

• Lead/oversee analytical qualification, validation, and transfer of analytical methods for small and large molecules.
• Review/approve analytical validation activities (Validation Protocol, Raw Data Review, Validation Report, Test methods).
• Serve as primary contact for analytical questions with cross-functional groups and vendors (deviations, OOS/OOT results, Change Controls, CAPA).
• Provide SME input to risk assessment and mitigation for product quality.
• Support stability programs with protocol reviews and data checks.
• Support analytical data review for regulatory submissions.

Skills

GxP Compliance

Analytical Method Validation

Cross-functional Collaboration

Regulatory Knowledge

Education

Bachelor's degree in life science or related field

Chemistry/Biology/Chemical Engineering preferred

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Quality Assurance - Technical to lead GxP analytical quality support and oversight for clinical and commercial testing. You will collaborate with cross‑functional teams and vendors to ensure analytical method validation, data integrity and regulatory compliance.

Responsibilities include leading qualification/validation/transfer of QC methods, managing deviations, CAPAs, change controls, and support for regulatory