Associate Director, Technical Operations Quality Control
Travere Therapeutics
August 29, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Associate Director, Technical Operations QC is responsible for managing Quality Control activities in compliance with GMP and international regulatory standards. Provides technical leadership and scientific decision-making for QC control strategies with knowledge of FDA, ICH, and EU requirements and ability to work effectively in a virtual environment.
Responsibilities:
- Coordinate and lead QC activities supporting drug substance and drug product manufacturing.
- Oversee specification development, batch release, and stability programs for drug substance and drug product at CMOs.
- Provide scientific/technical support to internal and external groups to ensure compliant testing and release.
- Provide QC oversight of stability programs (forced degradation, photostability, protocol approval, data review, trend analysis, internal stability reports for shelf-life).
- Support method transfer with Analytical Development.
- Support regulatory submissions/variations with Regulatory CMC.
- Support comparability assessments for process changes.
- Lead guidance/work with external vendors for OOS/OOT/atypical investigations and deviations; ensure scientifically sound, risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness and vendor audits.
Education/Experience:
- BS in Chemistry/Biochemistry or related life sciences (MS preferred). Equivalent combination may be considered.
- 8+ years in analytical operations/development or QC of biologics; late-stage drug development preferred.
- Knowledge of dissolution, HPLC, GC, MS, NMR, IR, UV and other analytical methods.
- Broad GMP environment and regulatory affairs knowledge.
Additional Skills/Experience:
- Courage, community spirit, patient focus, teamwork.
- Ability to adapt to changing project plans; strong interpersonal/organizational skills.
- Strong verbal/written communication; decision-making and collaboration; attention to detail.
- Manage multiple priorities in a fast-paced environment.
- Veeva/Quality Doc experience a plus.
- Travel 10–20% (domestic/international); not 100% remote.
Benefits (as listed):
- Premium health, financial, work-life/well-being; wellness/support programs; life insurance; disability; retirement match; generous paid time off.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.
The Associate Director, Technical Operations QC is responsible for managing Quality Control activities in compliance with GMP and international regulatory standards. Provides technical leadership and scientific decision-making for QC control strategies with knowledge of FDA, ICH, and EU requirements and ability to work effectively in a virtual environment.
Responsibilities:
- Coordinate and lead QC activities supporting drug substance and drug product manufacturing.
- Oversee specification development, batch release, and stability programs for drug substance and drug product at CMOs.
- Provide scientific/technical support to internal and external groups to ensure compliant testing and release.
- Provide QC oversight of stability programs (forced degradation, photostability, protocol approval, data review, trend analysis, internal stability reports for shelf-life).
- Support method transfer with Analytical Development.
- Support regulatory submissions/variations with Regulatory CMC.
- Support comparability assessments for process changes.
- Lead guidance/work with external vendors for OOS/OOT/atypical investigations and deviations; ensure scientifically sound, risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness and vendor audits.
Education/Experience:
- BS in Chemistry/Biochemistry or related life sciences (MS preferred). Equivalent combination may be considered.
- 8+ years in analytical operations/development or QC of biologics; late-stage drug development preferred.
- Knowledge of dissolution, HPLC, GC, MS, NMR, IR, UV and other analytical methods.
- Broad GMP environment and regulatory affairs knowledge.
Additional Skills/Experience:
- Courage, community spirit, patient focus, teamwork.
- Ability to adapt to changing project plans; strong interpersonal/organizational skills.
- Strong verbal/written communication; decision-making and collaboration; attention to detail.
- Manage multiple priorities in a fast-paced environment.
- Veeva/Quality Doc experience a plus.
- Travel 10–20% (domestic/international); not 100% remote.
Benefits (as listed):
- Premium health, financial, work-life/well-being; wellness/support programs; life insurance; disability; retirement match; generous paid time off.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.