Director, QA & Technical Validation — Remote

Travere Therapeutics; Des Moines (IA); Hybrid; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support for contract manufacturing, testing, storage and distribution across resources up to Phase 3 and commercialization.

You will lead validation efforts, oversee cGMP and regulatory reviews, and collaborate with Technical Operations to maintain robust quality systems and supplier management in a fast-paced, cross-functional setting.

Qualifications

• Bachelor's degree in life science or related field required; Master's preferred.
• 10 years of experience in QA or related field within FDA-regulated Biotech/Pharma industries.

Responsibilities

• Lead QA GMP functions with oversight of CSPs for Drug Substance/Drug Product through Phase 3 and commercialization.
• Lead validations: Process, FUE, Shipping, Cleaning, Test Methods, and Computer System Validation.
• Develop/oversee Master/Validation Plans, URS, FMEA, PV/Process Validation protocols and reports.
• Provide Change Control, Deviations/QA events, OOS/OOT investigations, CAPA.
• Vendor qualification and auditing; contractor qualification; risk management.
• Collaborate with Technical Operations to approve CSP documentation and ensure regulatory compliance.

Skills

QA GMP

FDA regulated

GxP knowledge

Project management

Vendor qualification

Regulatory compliance

Documentation review

Leadership

Cross-functional

Education

Bachelor's degree in life science or related field

Master's degree preferred

Job description

Travere Therapeutics is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support for contract manufacturing, testing, storage and distribution across resources up to Phase 3 and commercialization.

You will lead validation efforts, oversee cGMP and regulatory reviews, and collaborate with Technical Operations to maintain robust quality systems and supplier management in a fast-paced, cross-functional setting.