Associate Director, Technical Operations Quality Control
Travere Therapeutics
August 06, 2026
Remote friendly (United States)
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 extensive knowledge of FDA, ICH, and EU regulatory requirements; able 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 ensure products are tested and released per applicable regulations.
- QC oversight of stability programs: forced degradation and photostability (design through protocol approval, data review, trend analysis, and internal stability reports for shelf-life).
- Support method transfer with the Analytical Development team.
- Support QC for regulatory submissions and variations with Regulatory CMC.
- Support internal manufacturing comparability assessments for process changes.
- Guide external vendors during OOS/OOT/atypical results investigations and deviations; ensure scientifically sound, risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness and vendor audits.
Education/Experience Requirements:
- Bachelor’s degree in Chemistry/Biochemistry/related Life Sciences (Master’s preferred); equivalent experience may be considered.
- 8+ years in analytical operations, analytical 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:
- Values: courage, community spirit, patient focus, teamwork.
- Adaptability; strong interpersonal/organizational skills; independent and team work.
- Strong verbal/written communication; decision-making and attention to detail.
- Manage multiple priorities in a fast-paced environment.
- Veeva/Quality Doc a plus.
- Travel 10–20% domestically/internationally.
Benefits: premium health, financial, work-life/well-being, wellness programs, life insurance, disability, retirement with match, generous paid time off.
Application Instructions:
- Apply 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 extensive knowledge of FDA, ICH, and EU regulatory requirements; able 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 ensure products are tested and released per applicable regulations.
- QC oversight of stability programs: forced degradation and photostability (design through protocol approval, data review, trend analysis, and internal stability reports for shelf-life).
- Support method transfer with the Analytical Development team.
- Support QC for regulatory submissions and variations with Regulatory CMC.
- Support internal manufacturing comparability assessments for process changes.
- Guide external vendors during OOS/OOT/atypical results investigations and deviations; ensure scientifically sound, risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness and vendor audits.
Education/Experience Requirements:
- Bachelor’s degree in Chemistry/Biochemistry/related Life Sciences (Master’s preferred); equivalent experience may be considered.
- 8+ years in analytical operations, analytical 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:
- Values: courage, community spirit, patient focus, teamwork.
- Adaptability; strong interpersonal/organizational skills; independent and team work.
- Strong verbal/written communication; decision-making and attention to detail.
- Manage multiple priorities in a fast-paced environment.
- Veeva/Quality Doc a plus.
- Travel 10–20% domestically/internationally.
Benefits: premium health, financial, work-life/well-being, wellness programs, life insurance, disability, retirement with match, generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.