Director, Quality Assurance - Technical (GMP)

Travere Therapeutics; Columbia (SC); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Onsite in San Diego

Competitive compensation

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical in San Diego. This role provides QA guidance for contract manufacturing and testing, ensuring compliance with regulatory requirements through all stages up to commercialization.

The candidate will lead validation efforts, oversee CSP activities, and collaborate with Technical Operations to approve GMP documentation and ensure cGMP adherence across the supply chain.

Qualifications

• Bachelor's degree in Life Sciences required.
• 8+ years of GMP QA or Quality Systems experience in biotech/pharma.
• Experience with CFR/ICH and international guidelines is expected.

Responsibilities

• Provide and oversee QA GMP functions for CSPs up to Phase 3 and commercialization.
• Manage validation efforts: Process, FUE, shipping, cleaning, test methods, and computer system validation.
• Review and approve validation artifacts (VMP, VP, URS, FMEA, PV protocols/reports).
• Support vendor qualification, deviations, CAPAs, risk management and contractor qualification.

Skills

GMP QA

Leadership

Regulatory understanding

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical in San Diego. This role provides QA guidance for contract manufacturing and testing, ensuring compliance with regulatory requirements through all stages up to commercialization.

The candidate will lead validation efforts, oversee CSP activities, and collaborate with Technical Operations to approve GMP documentation and ensure cGMP adherence across the supply chain.