Analytical QA Director – Remote

Travere Therapeutics; Providence (RI); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, is seeking an Associate Director of Quality Assurance - Technical to lead GxP analytical quality/compliance for testing of therapeutic products in clinical and commercial use. The role partners with cross-functional teams and contract vendors to ensure robust analytics.

The preferred candidate has 8+ years in analytical QA, a life sciences degree, and strong knowledge of CFR/ICH regulations.

Qualifications

• Bachelor's degree in life science or related field required; equivalent combination may be considered.
• 8+ years in analytical function supporting drug/biologics development and commercialization in biotech/pharma.
• Direct experience in GMP Quality Assurance, Analytical Qualification/Validation and/or Quality Systems.
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.

Responsibilities

• Lead analytical qualification, validation and transfer of analytical methods for small and large molecules.
• Review and oversee analytical validation activities including method validation, raw data review, method validation report and test methods.
• Serve as primary point of contact for cross-functional groups and vendors for analytical issues and resolution of deviations or OOS/OOT results, change controls, CAPA.
• Provide SME in risk assessment to assess impact on product quality and mitigation recommendations.
• Support product stability programs with protocol/lab data review and final reports; contribute to regulatory submissions.

Skills

GxP Analytical quality

Analytical Qualification/Validation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in life science

8+ years in analytical function

Job description

Travere Therapeutics in San Diego, CA, is seeking an Associate Director of Quality Assurance - Technical to lead GxP analytical quality/compliance for testing of therapeutic products in clinical and commercial use. The role partners with cross-functional teams and contract vendors to ensure robust analytics.

The preferred candidate has 8+ years in analytical QA, a life sciences degree, and strong knowledge of CFR/ICH regulations.