Associate Director, Quality Assurance - Technical
Travere Therapeutics
August 30, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Associate Director, Quality Assurance - Technical, is responsible for leading and providing GxP Analytical quality/compliance support and/or oversight per requirements and applicable guidance. Works with cross-functional teams and contract vendors for analytical testing of product for clinical and commercial use.
Responsibilities:
- Lead and support analytical qualification, validation, and transfer of analytical methods for small and large molecules.
- Review, approve and/or oversee analytical validation activities, including method validation protocol, raw data review, method validation report, and test methods.
- Primary point of contact for analytical questions/issues/resolution with cross-functional groups and contract vendors:
- Laboratory deviations
- Out of specification/out of trend results
- Change controls
- CAPA
- Provide subject matter expertise for risk assessment and mitigation recommendations.
- Support product stability program (protocols, interim reports, raw data review, final reports).
- Support analytical review of data for regulatory submissions.
- Provide technical input to policies, SOPs, and work instructions.
- Maintain up-to-date knowledge of analytical regulatory requirements (e.g., FDA, ICH, EMA, USP).
- Support quality audits; contribute to inspections, audits, and due diligence.
- Support QA and Senior Management projects as needed.
Education/Experience Requirements:
- Bachelor’s degree in life science or related field required (Chemistry/Biology/Chemical Engineering preferred). Equivalent education/experience considered.
- 8+ years in analytical function supporting drug/biologics development and commercialization.
- Direct experience in GMP Quality Assurance and analytical qualification/validation and/or quality systems.
- Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations/guidelines.
Additional Skills/Experience:
- Embody Courage, Community Spirit, Patient Focus, Teamwork.
- Ability to analyze information, draw technical conclusions, influence approach, and resolve complex technical quality issues across functions.
- Strong interpersonal/organizational skills; excellent written and verbal communication.
- Problem-solving, urgency, attention to detail, ability to work independently, and manage multiple priorities.
- Travel 10–20% domestic/international.
- Must be able to perform face-to-face work/onsite in San Diego; not 100% remote.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Associate Director, Quality Assurance - Technical, is responsible for leading and providing GxP Analytical quality/compliance support and/or oversight per requirements and applicable guidance. Works with cross-functional teams and contract vendors for analytical testing of product for clinical and commercial use.
Responsibilities:
- Lead and support analytical qualification, validation, and transfer of analytical methods for small and large molecules.
- Review, approve and/or oversee analytical validation activities, including method validation protocol, raw data review, method validation report, and test methods.
- Primary point of contact for analytical questions/issues/resolution with cross-functional groups and contract vendors:
- Laboratory deviations
- Out of specification/out of trend results
- Change controls
- CAPA
- Provide subject matter expertise for risk assessment and mitigation recommendations.
- Support product stability program (protocols, interim reports, raw data review, final reports).
- Support analytical review of data for regulatory submissions.
- Provide technical input to policies, SOPs, and work instructions.
- Maintain up-to-date knowledge of analytical regulatory requirements (e.g., FDA, ICH, EMA, USP).
- Support quality audits; contribute to inspections, audits, and due diligence.
- Support QA and Senior Management projects as needed.
Education/Experience Requirements:
- Bachelor’s degree in life science or related field required (Chemistry/Biology/Chemical Engineering preferred). Equivalent education/experience considered.
- 8+ years in analytical function supporting drug/biologics development and commercialization.
- Direct experience in GMP Quality Assurance and analytical qualification/validation and/or quality systems.
- Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations/guidelines.
Additional Skills/Experience:
- Embody Courage, Community Spirit, Patient Focus, Teamwork.
- Ability to analyze information, draw technical conclusions, influence approach, and resolve complex technical quality issues across functions.
- Strong interpersonal/organizational skills; excellent written and verbal communication.
- Problem-solving, urgency, attention to detail, ability to work independently, and manage multiple priorities.
- Travel 10–20% domestic/international.
- Must be able to perform face-to-face work/onsite in San Diego; not 100% remote.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.