Associate Director, Quality Assurance - Technical
Travere Therapeutics
August 08, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Associate Director, Quality Assurance - Technical, provides GxP Analytical quality/compliance support and/or oversight 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 (Method Validation Protocol; Raw Data Review; Method Validation Report; test methods).
- Serve as primary point of contact for analytical questions/issues/resolution with cross-functional teams 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 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, guidance, and industry standards.
- Maintain current knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
- Support internal/external quality audits, inspections, audits, and due diligence; contribute to 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 in biotech/pharma required.
- Direct experience in GMP Quality Assurance, Analytical Qualification/Validation and/or Quality Systems.
- Broad cGMP (CFR/ICH) and international regulations/guidelines knowledge.
Additional Skills/Experience:
- Strong analytical/problem-solving, interpersonal, organizational, and verbal/written communication skills.
- Ability to manage multiple priorities; attention to detail; work independently.
- Travel up to 10–20% domestic/international.
- Face-to-face/onsite in San Diego required; not 100% remote.
Benefits (if eligible): premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with match, generous paid time off.
Application instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.
The Associate Director, Quality Assurance - Technical, provides GxP Analytical quality/compliance support and/or oversight 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 (Method Validation Protocol; Raw Data Review; Method Validation Report; test methods).
- Serve as primary point of contact for analytical questions/issues/resolution with cross-functional teams 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 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, guidance, and industry standards.
- Maintain current knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
- Support internal/external quality audits, inspections, audits, and due diligence; contribute to 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 in biotech/pharma required.
- Direct experience in GMP Quality Assurance, Analytical Qualification/Validation and/or Quality Systems.
- Broad cGMP (CFR/ICH) and international regulations/guidelines knowledge.
Additional Skills/Experience:
- Strong analytical/problem-solving, interpersonal, organizational, and verbal/written communication skills.
- Ability to manage multiple priorities; attention to detail; work independently.
- Travel up to 10–20% domestic/international.
- Face-to-face/onsite in San Diego required; not 100% remote.
Benefits (if eligible): premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with match, generous paid time off.
Application instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.