Director, Quality Assurance - Technical
Travere Therapeutics
August 30, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
Director, Quality Assurance – Technical (QA GMP) providing technical quality and compliance support/oversight of contract manufacturing, testing, storage & distribution, research and laboratory organizations.
Responsibilities:
- Lead/manage QA GMP functions and oversee GMP Contract Service Providers for Drug Substance/Drug Product activities/projects through Phase 3 Process Validation and commercialization.
- Lead validation efforts (Process; Facilities/Utilities/Equipment; Shipping; Cleaning; Test Methods; Computer System Validation) including VMP, VP, URS, FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ/OQ/PQ, and PV protocols/reports.
- Support contract manufacturing/testing/storage/distribution via Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor and contractor qualification/auditing.
- Collaborate with Technical Operations on review/approval of CSP documentation.
- Provide technical input to policies/SOPs/work instructions to meet regulatory/guidance/industry standards; review/approve GxP documents.
- Ensure compliance with laws/regulations/guidelines for contract manufacturing organizations; participate in project core teams; track progress vs. timelines/goals; other duties as assigned.
Qualifications:
- Bachelor’s in life science or related field required (Chemistry/Biology/Chemical Engineering preferred); Master’s preferred.
- 10 years in FDA-regulated industry in QA or related field required; biotech/pharma experience required.
Skills/Experience:
- Strong communication, organization, independent planning/prioritization/multitasking.
- Computer skills (MS Word, Excel, Adobe, PowerPoint).
- Working knowledge of cGMPs (CFR/ICH) and international regulations.
- Strong pharmaceutical QA/validation background (preferably small molecule); line management experience.
- Travel 10–25%; onsite in San Diego required (not 100% remote).
Benefits:
- Premium health/financial/work-life well-being, wellness support, life insurance, disability, retirement match, and generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.
Director, Quality Assurance – Technical (QA GMP) providing technical quality and compliance support/oversight of contract manufacturing, testing, storage & distribution, research and laboratory organizations.
Responsibilities:
- Lead/manage QA GMP functions and oversee GMP Contract Service Providers for Drug Substance/Drug Product activities/projects through Phase 3 Process Validation and commercialization.
- Lead validation efforts (Process; Facilities/Utilities/Equipment; Shipping; Cleaning; Test Methods; Computer System Validation) including VMP, VP, URS, FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ/OQ/PQ, and PV protocols/reports.
- Support contract manufacturing/testing/storage/distribution via Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor and contractor qualification/auditing.
- Collaborate with Technical Operations on review/approval of CSP documentation.
- Provide technical input to policies/SOPs/work instructions to meet regulatory/guidance/industry standards; review/approve GxP documents.
- Ensure compliance with laws/regulations/guidelines for contract manufacturing organizations; participate in project core teams; track progress vs. timelines/goals; other duties as assigned.
Qualifications:
- Bachelor’s in life science or related field required (Chemistry/Biology/Chemical Engineering preferred); Master’s preferred.
- 10 years in FDA-regulated industry in QA or related field required; biotech/pharma experience required.
Skills/Experience:
- Strong communication, organization, independent planning/prioritization/multitasking.
- Computer skills (MS Word, Excel, Adobe, PowerPoint).
- Working knowledge of cGMPs (CFR/ICH) and international regulations.
- Strong pharmaceutical QA/validation background (preferably small molecule); line management experience.
- Travel 10–25%; onsite in San Diego required (not 100% remote).
Benefits:
- Premium health/financial/work-life well-being, wellness support, life insurance, disability, retirement match, and generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.