Analytical QA Director – Remote

Travere Therapeutics

Providence (RI)

Hybrid

USD 150,000 - 195,000

Full time

14 days+

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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.