Director, Quality Assurance - Technical
Travere Therapeutics
August 08, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Director, Quality Assurance - Technical provides technical quality and compliance support and/or oversight of contract manufacturing, testing, storage and distribution, research and/or laboratory organizations.
Responsibilities:
- Lead, manage, and perform critical QA GMP functions providing oversight of GMP Contract Service Providers (CSPs) for Drug Substance and Drug Product activities/projects leading up to Phase 3 Process Validation and Commercialization.
- Lead validation efforts including validations of: Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning; Test Methods; Computer System Validation.
- Develop, execute, review, approve and/or oversee validation activities (e.g., VMP, VP, URS, Process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ/OQ/PQ, PV protocols/reports).
- Direct support of contract manufacturing/testing/storage/distribution organizations including Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor and contractor qualification.
- Collaborate with Technical Operations to review/approve CSP documentation; provide technical input to policies/SOPs/Work Instructions; review and approve Travere GxP documents as requested; ensure compliance with applicable laws/regulations/guidelines.
- Participate in project core teams; track progress vs. timelines/goals; perform other duties as needed.
Education/Experience Requirements:
- Bachelor’s degree in life science or related field required (Chemistry/Biology/Chemical Engineering preferred); Master’s preferred.
- 10 years in an FDA-regulated industry in QA or related field; experience in biotech or pharmaceutical industry required.
Additional Skills/Experience (selected):
- Strong cGMP (CFR/ICH) knowledge; FDA/international regulatory knowledge.
- Excellent communication, organization, multitasking, collaboration, and attention to detail.
- Prior line management experience.
- Proven ability to manage complex project plans/timelines/budgets.
- Problem-solving, urgency, ability to work independently.
- Ability to travel 10–25%.
- Must be able to perform face-to-face/onsite in San Diego (not 100% remote).
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Director, Quality Assurance - Technical provides technical quality and compliance support and/or oversight of contract manufacturing, testing, storage and distribution, research and/or laboratory organizations.
Responsibilities:
- Lead, manage, and perform critical QA GMP functions providing oversight of GMP Contract Service Providers (CSPs) for Drug Substance and Drug Product activities/projects leading up to Phase 3 Process Validation and Commercialization.
- Lead validation efforts including validations of: Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning; Test Methods; Computer System Validation.
- Develop, execute, review, approve and/or oversee validation activities (e.g., VMP, VP, URS, Process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ/OQ/PQ, PV protocols/reports).
- Direct support of contract manufacturing/testing/storage/distribution organizations including Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor and contractor qualification.
- Collaborate with Technical Operations to review/approve CSP documentation; provide technical input to policies/SOPs/Work Instructions; review and approve Travere GxP documents as requested; ensure compliance with applicable laws/regulations/guidelines.
- Participate in project core teams; track progress vs. timelines/goals; perform other duties as needed.
Education/Experience Requirements:
- Bachelor’s degree in life science or related field required (Chemistry/Biology/Chemical Engineering preferred); Master’s preferred.
- 10 years in an FDA-regulated industry in QA or related field; experience in biotech or pharmaceutical industry required.
Additional Skills/Experience (selected):
- Strong cGMP (CFR/ICH) knowledge; FDA/international regulatory knowledge.
- Excellent communication, organization, multitasking, collaboration, and attention to detail.
- Prior line management experience.
- Proven ability to manage complex project plans/timelines/budgets.
- Problem-solving, urgency, ability to work independently.
- Ability to travel 10–25%.
- Must be able to perform face-to-face/onsite in San Diego (not 100% remote).
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.