Associate Director, QA & GMP Compliance - Remote

Travere Therapeutics; Atlanta (GA); À distance; USD 150 000 - 195 000; Plein temps

Avantages offerts par ce poste

Premium health insurance

Employer-matched retirement

Generous PTO

Life insurance

Disability insurance

Employee assistance programs

Résumé du poste

Travere Therapeutics seeks an Associate Director, Quality Assurance - Technical in San Diego (Remote). Lead GMP QA functions overseeing CSPs for Drug Substance and Drug Product through Phase 3 and commercialization.

Provide guidance on validation, QA systems, and regulatory alignment. The role requires a Bachelor's in Life Sciences and 8+ years in GMP QA within biotech/pharma, with strong CFR/ICH knowledge, leadership, and collaboration across departments.

Qualifications

• Bachelor's degree in a Life Sciences discipline required; Master's preferred.
• 8+ years of direct GMP QA or related experience in biotech/pharma.
• Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsabilités

• Lead QA GMP functions overseeing CSPs for drug substance/product up to Phase 3 and commercialization.
• Manage and review validation activities (VMP, VP, URS, FMEA, PC/PU, PV).
• Support vendor qualification, change control, deviations, CAPA and risk management.
• Collaborate with Technical Operations for CSP documentation and regulatory alignment.
• Ensure compliance with laws and Travere SOPs and GxP documents.
• Travel 10–25% domestically and internationally.
• Participate in project teams and track timelines.

Connaissances

GMP QA

cGMP CFR/ICH

Regulatory knowledge

Leadership

Communication

Travel ready

Formation

Bachelor's in Life Sciences

Master's degree preferred

Description du poste

Travere Therapeutics seeks an Associate Director, Quality Assurance - Technical in San Diego (Remote). Lead GMP QA functions overseeing CSPs for Drug Substance and Drug Product through Phase 3 and commercialization.

Provide guidance on validation, QA systems, and regulatory alignment. The role requires a Bachelor's in Life Sciences and 8+ years in GMP QA within biotech/pharma, with strong CFR/ICH knowledge, leadership, and collaboration across departments.