Associate Director, Quality Assurance - Technical
Travere Therapeutics
August 30, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Associate Director, Quality Assurance - Technical, leads and provides GxP Analytical quality/compliance support and/or oversight per requirements and applicable guidance, working closely with cross-functional teams and contract vendors for 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.
- Serve as primary point of contact for analytical questions/issues/resolution with cross-functional groups and vendors, including laboratory deviations, OOS/OOT results, change controls, and 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/work instructions to meet regulatory requirements and industry standards.
- Maintain up-to-date knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
- Aid in quality audits and support inspections, audits, and due diligence; support QA and Senior Management projects.
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 and commercialization.
- Direct experience in GMP Quality Assurance and Analytical Qualification/Validation and/or Quality Systems.
- Broad knowledge of cGMPs (CFR/ICH) and international regulations/guidelines.
Additional Skills/Experience:
- Strong analytical judgment; ability to resolve complex technical quality issues across internal/external teams.
- Strong interpersonal/organizational skills; excellent verbal and written communication.
- Problem-solving, urgency, attention to detail, independence, and ability to manage multiple priorities.
- Travel up to 10–20%.
- Essential function requires face-to-face/onsite work in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/employee support programs; life insurance, disability; retirement plans with employer match; generous paid time off.
- Target Base Pay Range: $150,000.00–$195,000.00 (plus cash/short-term incentive and long-term incentive/company stock).
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Associate Director, Quality Assurance - Technical, leads and provides GxP Analytical quality/compliance support and/or oversight per requirements and applicable guidance, working closely with cross-functional teams and contract vendors for 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.
- Serve as primary point of contact for analytical questions/issues/resolution with cross-functional groups and vendors, including laboratory deviations, OOS/OOT results, change controls, and 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/work instructions to meet regulatory requirements and industry standards.
- Maintain up-to-date knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
- Aid in quality audits and support inspections, audits, and due diligence; support QA and Senior Management projects.
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 and commercialization.
- Direct experience in GMP Quality Assurance and Analytical Qualification/Validation and/or Quality Systems.
- Broad knowledge of cGMPs (CFR/ICH) and international regulations/guidelines.
Additional Skills/Experience:
- Strong analytical judgment; ability to resolve complex technical quality issues across internal/external teams.
- Strong interpersonal/organizational skills; excellent verbal and written communication.
- Problem-solving, urgency, attention to detail, independence, and ability to manage multiple priorities.
- Travel up to 10–20%.
- Essential function requires face-to-face/onsite work in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/employee support programs; life insurance, disability; retirement plans with employer match; generous paid time off.
- Target Base Pay Range: $150,000.00–$195,000.00 (plus cash/short-term incentive and long-term incentive/company stock).
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.