Associate Director, Technical Operations Quality Control
Travere Therapeutics
June 25, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Associate Director, Technical Operations QC is responsible for managing Quality Control activities at Travere in compliance with GMP and international regulatory standards (FDA, ICH, EU). Provides technical leadership and scientific decision-making for QC control strategies 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 at Contract Manufacturing Organizations (CMOs).
- Provide scientific/technical support to ensure products are tested and released per applicable regulations.
- Provide QC oversight of stability programs (forced degradation, photostability; protocol approval, data review, trend analysis, stability reports for shelf-life).
- Support method transfer with Analytical Development.
- Support regulatory CMC submissions/variations preparation and QC.
- Support manufacturing comparability assessments for process changes.
- Guide/partner with external vendors on OOS/OOT/atypical results, investigations, deviations; ensure risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness and vendor audits.
Education/Experience Requirements:
- Bachelor’s in Chemistry/Biochemistry/related Life Sciences required; Master’s preferred.
- 8+ years in analytical operations/development or QC of biologics; late-stage preferred.
- Knowledge of dissolution, HPLC, GC, MS, NMR, IR, UV and other analytical methods.
- Broad GMP and regulatory affairs knowledge.
Additional Skills/Experience (Preferred):
- Values alignment: Courage, Community Spirit, Patient Focus, Teamwork.
- Strong communication, decision-making, attention to detail, and ability to manage multiple priorities.
- Experience with Veeva/Quality Doc a plus.
- Travel 10–20%.
- Onsite presence in San Diego required as an essential function; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness programs; life insurance; disability; retirement match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Associate Director, Technical Operations QC is responsible for managing Quality Control activities at Travere in compliance with GMP and international regulatory standards (FDA, ICH, EU). Provides technical leadership and scientific decision-making for QC control strategies 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 at Contract Manufacturing Organizations (CMOs).
- Provide scientific/technical support to ensure products are tested and released per applicable regulations.
- Provide QC oversight of stability programs (forced degradation, photostability; protocol approval, data review, trend analysis, stability reports for shelf-life).
- Support method transfer with Analytical Development.
- Support regulatory CMC submissions/variations preparation and QC.
- Support manufacturing comparability assessments for process changes.
- Guide/partner with external vendors on OOS/OOT/atypical results, investigations, deviations; ensure risk-based reports and appropriate CAPAs.
- Serve as SME for QA PAI readiness and vendor audits.
Education/Experience Requirements:
- Bachelor’s in Chemistry/Biochemistry/related Life Sciences required; Master’s preferred.
- 8+ years in analytical operations/development or QC of biologics; late-stage preferred.
- Knowledge of dissolution, HPLC, GC, MS, NMR, IR, UV and other analytical methods.
- Broad GMP and regulatory affairs knowledge.
Additional Skills/Experience (Preferred):
- Values alignment: Courage, Community Spirit, Patient Focus, Teamwork.
- Strong communication, decision-making, attention to detail, and ability to manage multiple priorities.
- Experience with Veeva/Quality Doc a plus.
- Travel 10–20%.
- Onsite presence in San Diego required as an essential function; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness programs; life insurance; disability; retirement match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.