GMP Quality Assurance Lead – Associate Director

Travere Therapeutics; Wichita (KS); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, with remote flexibility, is seeking an Associate Director of Quality Assurance - Technical to provide technical quality guidance across contract manufacturing, testing, storage, and distribution.

You will lead GMP QA functions, oversee CSPs through Phase 3, manage validation efforts, and drive CAPA, change control, and risk management while ensuring compliance with CFR/ICH and regulatory standards.

Qualifications

• Bachelor’s degree in Chemistry, Biology or Chemical Engineering; Master’s preferred.

Responsibilities

• Lead GMP QA functions overseeing CSPs for Drug Substance and Drug Product through Phase 3 and Commercialization.
• Manage validation activities including VMP, VP, URS, FMEA, PC/PU, PV protocols/reports.
• Review and approve CSP documentation and ensure regulatory inspection readiness.
• Support vendor qualification, deviations, CAPA, change control, risk management and contractor qualification.
• Collaborate with Technical Operations to ensure regulatory compliance of GxP documents.

Skills

GMP QA experience

Quality systems

Regulatory compliance

cGMP CFR/ICH

Leadership & communication

Problem solving

Education

Bachelor’s degree in Life Sciences

Master’s degree preferred

Tools

GxP documentation

Job description

Travere Therapeutics in San Diego, with remote flexibility, is seeking an Associate Director of Quality Assurance - Technical to provide technical quality guidance across contract manufacturing, testing, storage, and distribution.

You will lead GMP QA functions, oversee CSPs through Phase 3, manage validation efforts, and drive CAPA, change control, and risk management while ensuring compliance with CFR/ICH and regulatory standards.