Director, Quality Assurance - Technical
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Director, Quality Assurance - Technical is responsible for providing technical quality and compliance support and/or oversight of the 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 for Drug Substance and Drug Product activities leading up to Phase 3 Process Validation and Commercialization.
- Lead validation efforts including Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning; Test Methods; and Computer System Validation.
- Develop/execute/review/approve/oversee validation activities including VMP, VP, URS, Process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ, OQ, PQ, and PV protocols/reports.
- Direct support of contract manufacturing/testing/storage/distribution organizations: Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor qualification/auditing, and contractor qualification.
- 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/guidelines.
- Participate in core teams/sub-teams; track progress vs timelines/goals; other duties as assigned.
Education/Experience Requirements:
- Bachelor’s degree 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.
Additional Skills/Experience:
- Working knowledge of cGMPs (CFR/ICH) and international regulations/guidelines.
- Strong communication, organization, multi-tasking, collaboration, attention to detail.
- Computer skills (MS Word/Excel/Adobe/PowerPoint).
- Strong experience in similar pharmaceutical QA/technical role (preferably small molecule).
- Line management experience.
- Ability to manage complex project plans/timelines/budgets/critical paths; adapt to changes.
- Problem-solving, urgency, independence; travel 10–25%.
- Must be able to perform face-to-face work and/or onsite in San Diego; not 100% remote.
Total Rewards (Benefits):
- Premium health, financial, work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement plans with employer match, and generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Director, Quality Assurance - Technical is responsible for providing technical quality and compliance support and/or oversight of the 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 for Drug Substance and Drug Product activities leading up to Phase 3 Process Validation and Commercialization.
- Lead validation efforts including Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning; Test Methods; and Computer System Validation.
- Develop/execute/review/approve/oversee validation activities including VMP, VP, URS, Process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ, OQ, PQ, and PV protocols/reports.
- Direct support of contract manufacturing/testing/storage/distribution organizations: Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor qualification/auditing, and contractor qualification.
- 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/guidelines.
- Participate in core teams/sub-teams; track progress vs timelines/goals; other duties as assigned.
Education/Experience Requirements:
- Bachelor’s degree 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.
Additional Skills/Experience:
- Working knowledge of cGMPs (CFR/ICH) and international regulations/guidelines.
- Strong communication, organization, multi-tasking, collaboration, attention to detail.
- Computer skills (MS Word/Excel/Adobe/PowerPoint).
- Strong experience in similar pharmaceutical QA/technical role (preferably small molecule).
- Line management experience.
- Ability to manage complex project plans/timelines/budgets/critical paths; adapt to changes.
- Problem-solving, urgency, independence; travel 10–25%.
- Must be able to perform face-to-face work and/or onsite in San Diego; not 100% remote.
Total Rewards (Benefits):
- Premium health, financial, work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement plans with employer match, and generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.