Remote Director, Quality Assurance – Technical

Travere Therapeutics; Columbus (OH); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Health benefits

Retirement plans

Paid time off

Stock option/RSUs

Job summary

Travere Therapeutics is seeking a Director, Quality Assurance - Technical to provide expert QA and regulatory oversight for GMP CSPs, spanning Drug Substance and Drug Product activities toward Phase 3 and commercialization.

The role requires leading validation, change control, deviations, OOS/OOT, risk management, and supplier qualification while ensuring compliance with CFR/ICH and global guidelines; travel up to 25% domestically and internationally; on-site in San Diego is required.

Qualifications

• Bachelor's degree in life science required; Master’s degree preferred.
• 10+ years of experience in a FDA-regulated QA environment in biotech/pharma.

Responsibilities

• Provide technical quality and compliance support for GMP Contract Service Providers (CSPs) from Drug Substance to Commercialization.
• Lead validation activities including Process, Facilities, Utilities, Equipment, and Test Methods validation.
• Develop/approve Master Plan, VP, URS, FMEA, PV protocols and reports.
• Oversee change control, deviations, OOS/OOT investigations, CAPA, risk management, and vendor qualification.
• Collaborate with Technical Operations to approve CSP documentation and ensure regulatory compliance.

Skills

cGMPs knowledge

QA leadership

Regulatory compliance

Communication skills

Education

Bachelor's degree in life science

Master's degree preferred

Tools

MS Word

Excel

Adobe

PowerPoint

Job description

Travere Therapeutics is seeking a Director, Quality Assurance - Technical to provide expert QA and regulatory oversight for GMP CSPs, spanning Drug Substance and Drug Product activities toward Phase 3 and commercialization.

The role requires leading validation, change control, deviations, OOS/OOT, risk management, and supplier qualification while ensuring compliance with CFR/ICH and global guidelines; travel up to 25% domestically and internationally; on-site in San Diego is required.