QA & Validation Lead – GMP Compliance (Remote)

Travere Therapeutics; Des Moines (IA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Stock incentives

Retirement plans with company match

Job summary

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, seeks an Associate Director, Quality Assurance - Technical in San Diego with remote flexibility. You will provide technical quality guidance and oversight of GMP CSPs, participate in validation activities and maintain regulatory compliance across Drug Substance and Drug Product.

The role collaborates with Technical Operations, reviews GxP documents and supports change control, deviations, CAPA and risk management.

Qualifications

• Bachelor's degree in life sciences; master's preferred.
• 8+ years of GMP QA or quality systems experience in biotech/pharma.

Responsibilities

• Provide QA GMP oversight for CSPs for Drug Substance and Drug Product up to Phase 3 and commercialization.
• Manage validation efforts including VMPs, VP, URS, FMEA, PC/PU, PV protocols/reports.
• Support change control, deviations/quality events, OOS/OOT investigations, CAPA, risk management, vendor qualification, and contractor qualification.
• Collaborate with Technical Operations for CSP documentation reviews and regulatory-compliant SOPs and GxP documents.
• Track progress against timelines and contribute to project teams as needed.

Skills

GMP knowledge

Regulatory compliance

Communication skills

Leadership experience

Education

B.S./B.A. in Life Sciences

Job description

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, seeks an Associate Director, Quality Assurance - Technical in San Diego with remote flexibility. You will provide technical quality guidance and oversight of GMP CSPs, participate in validation activities and maintain regulatory compliance across Drug Substance and Drug Product.

The role collaborates with Technical Operations, reviews GxP documents and supports change control, deviations, CAPA and risk management.