Associate Director, QA – GMP & Validation Leadership
Travere Therapeutics
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Benefits offered by this job
Job summary
Travere Therapeutics seeks an Associate Director, Quality Assurance - Technical to provide and oversee technical quality and regulatory compliance for contract manufacturing, testing, storage and distribution up to Phase 3 and commercialization.
The role requires 8+ years in GMP QA, a Life Sciences degree (Master's preferred), and strong CFR/ICH knowledge, with leadership experience and up to 25% travel. Onsite in San Diego with collaborative cross-functional engagement.
Qualifications
- 8+ years of direct GMP QA experience
- Experience in Biotech or Pharmaceutical industry
- Strong written and verbal communication skills
Responsibilities
- Lead, manage and perform QA GMP functions overseeing CSPs for Drug Substance/Product up to Phase 3
- Manage validation efforts including VMP/VP/URS and PV protocols
- Review and approve validation activities and related documentation (FMEA, PC/PU, PV reports)
- Support vendor qualification, changes, deviations, OOS/OOT investigations
- Collaborate with Technical Operations to approve CSP documentation
- Ensure compliance with CFR/ICH and international guidelines
- Track progress against timelines and goals
- Travel 10–25% domestically and internationally
Skills
Education
Job description
Travere Therapeutics seeks an Associate Director, Quality Assurance - Technical to provide and oversee technical quality and regulatory compliance for contract manufacturing, testing, storage and distribution up to Phase 3 and commercialization.
The role requires 8+ years in GMP QA, a Life Sciences degree (Master's preferred), and strong CFR/ICH knowledge, with leadership experience and up to 25% travel. Onsite in San Diego with collaborative cross-functional engagement.
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