Associate Director, Technical QA – Remote

Travere; United States; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director of Quality Assurance - Technical to provide and oversee GMP quality guidance across contract manufacturing, testing, storage and distribution. This role leads validation efforts and ensures compliance with CFR/ICH and international guidelines.

Ideal candidates will have 8+ years in GMP QA, a Life Sciences degree (Master’s preferred), and strong team leadership abilities to support Phase 3 and commercial efforts at Travere’s San Diego area

Qualifications

• Bachelor's degree in Life Sciences or related field; Master’s preferred.
• 8+ years in GMP QA or Quality Systems within biotech/pharma.
• Experience with CSP oversight and regulatory compliance.

Responsibilities

• Provide QA GMP guidance for CSPs handling drug substance/product.
• Lead validation efforts: process, facilities, equipment, cleaning, and computer systems.
• Review and approve validation Master Plans, VP, URS, PV protocols/reports.
• Support change controls, deviations, OOS/OOT investigations, CAPAs.
• Collaborate with Technical Operations and ensure regulatory compliance.

Skills

GMP Quality Assurance

Quality Systems

Validation

Project management

Regulatory compliance

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Job description

Travere Therapeutics is seeking an Associate Director of Quality Assurance - Technical to provide and oversee GMP quality guidance across contract manufacturing, testing, storage and distribution. This role leads validation efforts and ensures compliance with CFR/ICH and international guidelines.

Ideal candidates will have 8+ years in GMP QA, a Life Sciences degree (Master’s preferred), and strong team leadership abilities to support Phase 3 and commercial efforts at Travere’s San Diego area