Associate Director, Quality Assurance - Technical
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
Associate Director, Quality Assurance - Technical, providing GxP Analytical quality/compliance support and/or oversight for analytical testing of product for clinical and commercial use.
Responsibilities:
- Lead/support analytical qualification, validation, and transfer of methods for small and large molecules.
- Review/approve/oversee analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, test methods).
- Primary point of contact for analytical questions/issues with cross-functional teams and contract vendors, including Laboratory Deviations, OOS/Out of Trend, Change Controls, and CAPA.
- Provide subject matter expertise for risk assessments; support mitigation recommendations.
- Support product stability programs (protocols, interim reports, raw data review, final reports).
- Support analytical review of data for regulatory submissions.
- Provide technical input to policies/SOPs/work instructions to meet regulatory requirements and industry standards.
- Maintain knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
- Support internal/external quality audits, inspections, audits, and due diligence as needed.
Education/Experience Requirements:
- Bachelor’s degree in life science or related field required; Chemistry/Biology/Chemical Engineering preferred.
- 8+ years in analytical function supporting drug/biologics development/commercialization.
- Direct GMP Quality Assurance and Analytical Qualification/Validation and/or Quality Systems experience.
- Broad cGMP knowledge (CFR/ICH) and international regulations/guidelines.
Additional Skills/Experience:
- Strong analytical problem-solving, communication, organization, urgency, attention to detail.
- Ability to work independently, manage multiple priorities; travel 10–20%.
- Face-to-face/onsite in San Diego required (not 100% remote).
Benefits/Compensation:
- Premium health, financial, work-life/well-being benefits; life insurance; disability; retirement match; generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Accepting applications on an ongoing basis until selected.
Associate Director, Quality Assurance - Technical, providing GxP Analytical quality/compliance support and/or oversight for analytical testing of product for clinical and commercial use.
Responsibilities:
- Lead/support analytical qualification, validation, and transfer of methods for small and large molecules.
- Review/approve/oversee analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, test methods).
- Primary point of contact for analytical questions/issues with cross-functional teams and contract vendors, including Laboratory Deviations, OOS/Out of Trend, Change Controls, and CAPA.
- Provide subject matter expertise for risk assessments; support mitigation recommendations.
- Support product stability programs (protocols, interim reports, raw data review, final reports).
- Support analytical review of data for regulatory submissions.
- Provide technical input to policies/SOPs/work instructions to meet regulatory requirements and industry standards.
- Maintain knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
- Support internal/external quality audits, inspections, audits, and due diligence as needed.
Education/Experience Requirements:
- Bachelor’s degree in life science or related field required; Chemistry/Biology/Chemical Engineering preferred.
- 8+ years in analytical function supporting drug/biologics development/commercialization.
- Direct GMP Quality Assurance and Analytical Qualification/Validation and/or Quality Systems experience.
- Broad cGMP knowledge (CFR/ICH) and international regulations/guidelines.
Additional Skills/Experience:
- Strong analytical problem-solving, communication, organization, urgency, attention to detail.
- Ability to work independently, manage multiple priorities; travel 10–20%.
- Face-to-face/onsite in San Diego required (not 100% remote).
Benefits/Compensation:
- Premium health, financial, work-life/well-being benefits; life insurance; disability; retirement match; generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Accepting applications on an ongoing basis until selected.