Director, Quality Assurance - Technical
Travere Therapeutics
August 30, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
Director, Quality Assurance – Technical. Provide technical quality and compliance support/oversight for contract manufacturing, testing, storage and distribution, research, and/or laboratory organizations.
Responsibilities:
- Lead, manage, and perform critical QA GMP functions; oversee GMP Contract Service Providers for Drug Substance/Product activities/projects up to Phase 3 Process Validation and Commercialization.
- Lead validation efforts and actions, including validations of Process; Facilities/Utilities/Equipment; Shipping; Cleaning; Test Methods; and Computer System Validation.
- Develop/execute/review/approve/oversee validation deliverables: VMP, VP, URS, process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ, OQ, PQ, PV protocols/reports.
- Support contract manufacturing/testing/storage/distribution: Change Control; Deviations/Quality Events; OOS/OOT investigations; CAPA; Risk Management; vendor and contractor qualification/auditing.
- Collaborate with Technical Operations to review/approve CSP documentation; provide technical input to policies/SOPs/work instructions; review/approve GxP documents; ensure compliance with applicable laws/regulations/guidance.
- Participate in core/project teams; track progress vs. timelines/goals.
Qualifications:
- Bachelor’s in life science or related field required (Chemistry/Biology/Chemical Engineering preferred). Master’s preferred.
- 10 years in FDA-regulated QA or related field required; biotech/pharma experience required.
Skills/Experience:
- cGMP (CFR/ICH) and international regulatory knowledge; strong communication, organization, multitasking, collaboration, and attention to detail.
- Line management experience.
- Experience managing complex project plans/timelines/budgets/critical paths; strong problem-solving.
- Travel 10–25%.
- Not 100% remote; ability to work onsite/face-to-face in San Diego.
Benefits:
- Premium health, financial, work-life/well-being benefits; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Compensation:
- Target base pay range: $189,000–$246,000.
Application:
- Travere will accept applications on an ongoing basis until a candidate is selected.
Director, Quality Assurance – Technical. Provide technical quality and compliance support/oversight for contract manufacturing, testing, storage and distribution, research, and/or laboratory organizations.
Responsibilities:
- Lead, manage, and perform critical QA GMP functions; oversee GMP Contract Service Providers for Drug Substance/Product activities/projects up to Phase 3 Process Validation and Commercialization.
- Lead validation efforts and actions, including validations of Process; Facilities/Utilities/Equipment; Shipping; Cleaning; Test Methods; and Computer System Validation.
- Develop/execute/review/approve/oversee validation deliverables: VMP, VP, URS, process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ, OQ, PQ, PV protocols/reports.
- Support contract manufacturing/testing/storage/distribution: Change Control; Deviations/Quality Events; OOS/OOT investigations; CAPA; Risk Management; vendor and contractor qualification/auditing.
- Collaborate with Technical Operations to review/approve CSP documentation; provide technical input to policies/SOPs/work instructions; review/approve GxP documents; ensure compliance with applicable laws/regulations/guidance.
- Participate in core/project teams; track progress vs. timelines/goals.
Qualifications:
- Bachelor’s in life science or related field required (Chemistry/Biology/Chemical Engineering preferred). Master’s preferred.
- 10 years in FDA-regulated QA or related field required; biotech/pharma experience required.
Skills/Experience:
- cGMP (CFR/ICH) and international regulatory knowledge; strong communication, organization, multitasking, collaboration, and attention to detail.
- Line management experience.
- Experience managing complex project plans/timelines/budgets/critical paths; strong problem-solving.
- Travel 10–25%.
- Not 100% remote; ability to work onsite/face-to-face in San Diego.
Benefits:
- Premium health, financial, work-life/well-being benefits; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Compensation:
- Target base pay range: $189,000–$246,000.
Application:
- Travere will accept applications on an ongoing basis until a candidate is selected.