Associate Director, Technical Operations Quality Control
Travere Therapeutics
August 07, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Associate Director, Technical Operations QC manages 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.
Responsibilities:
- Coordinate and lead QC activities for drug substance and drug product manufacturing.
- Oversee specification development, batch release, and stability programs at CMOs.
- Provide scientific/technical support to ensure products are tested and released per regulations.
- Oversee stability studies (forced degradation, photostability), including protocol approval, data review, trend analysis, and internal stability reports for shelf-life.
- Support method transfer with Analytical Development.
- Support regulatory submissions and variations with Regulatory CMC.
- Support internal manufacturing comparability assessments for process changes.
- Guide external vendors during OOS/OOT/atypical result investigations and deviations; ensure scientifically sound, risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness activities and vendor audits.
Education/Experience Requirements:
- Bachelor’s degree in Chemistry/Biochemistry or related Life Sciences; Master’s preferred.
- 8+ years in analytical operations, analytical development, or quality control of biologics (late-stage experience preferred).
- Knowledge of dissolution and analytical methods (HPLC, GC, MS, NMR, IR, UV, etc.).
- Broad GMP and regulatory affairs experience.
Additional Skills/Experience:
- Values: Courage, Community Spirit, Patient Focus, Teamwork.
- Strong communication; decision-making; attention to detail; ability to manage multiple priorities.
- Ability to work independently and in teams; adapt to changing project plans.
- Experience with Veeva/Quality Doc a plus.
- Travel 10–20% and onsite/face-to-face work in San Diego required; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness support; life insurance; disability; retirement match; generous paid time off.
Compensation:
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Associate Director, Technical Operations QC manages 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.
Responsibilities:
- Coordinate and lead QC activities for drug substance and drug product manufacturing.
- Oversee specification development, batch release, and stability programs at CMOs.
- Provide scientific/technical support to ensure products are tested and released per regulations.
- Oversee stability studies (forced degradation, photostability), including protocol approval, data review, trend analysis, and internal stability reports for shelf-life.
- Support method transfer with Analytical Development.
- Support regulatory submissions and variations with Regulatory CMC.
- Support internal manufacturing comparability assessments for process changes.
- Guide external vendors during OOS/OOT/atypical result investigations and deviations; ensure scientifically sound, risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness activities and vendor audits.
Education/Experience Requirements:
- Bachelor’s degree in Chemistry/Biochemistry or related Life Sciences; Master’s preferred.
- 8+ years in analytical operations, analytical development, or quality control of biologics (late-stage experience preferred).
- Knowledge of dissolution and analytical methods (HPLC, GC, MS, NMR, IR, UV, etc.).
- Broad GMP and regulatory affairs experience.
Additional Skills/Experience:
- Values: Courage, Community Spirit, Patient Focus, Teamwork.
- Strong communication; decision-making; attention to detail; ability to manage multiple priorities.
- Ability to work independently and in teams; adapt to changing project plans.
- Experience with Veeva/Quality Doc a plus.
- Travel 10–20% and onsite/face-to-face work in San Diego required; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness support; life insurance; disability; retirement match; generous paid time off.
Compensation:
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.