Associate Director, Quality Assurance – GMP Leader (Remote)

Travere Therapeutics; San Diego (CA); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Retirement plans

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical in San Diego to provide and oversee technical quality guidance for contract manufacturing, testing, storage and distribution entities. You will lead GMP QA functions for CSPs, manage validation efforts, and ensure rigorous compliance with CFR/ICH guidelines.

The role requires a Bachelor’s in life sciences with 8+ years in GMP QA, preferably in biotech or pharma, and readiness to travel 10-25% internationally.

Qualifications

• Bachelor’s degree in life sciences; Master’s degree preferred.
• 8+ years of direct GMP Quality Assurance experience in Biotech/Pharma.
• Broad working knowledge of cGMPs (CFR/ICH) and international guidelines.

Responsibilities

• Lead and oversee GMP QA functions for CSPs from Drug Substance to Commercialization.
• Manage validation activities: PV, URS, FMEA, PC/PU, and related reports.
• Support CSP documentation and change controls; investigate deviations and CAPAs.
• Collaborate with Technical Operations to review CSP documentation and ensure compliance.
• Provide input to SOPs and GxP documents; ensure regulatory compliance.

Skills

GMP QA

Quality Systems

Regulatory Knowledge CFR/ICH

Education

Bachelor’s degree in life sciences (Chemistry, Biology, or Chemical Engineering)

Master’s degree preferred

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical in San Diego to provide and oversee technical quality guidance for contract manufacturing, testing, storage and distribution entities. You will lead GMP QA functions for CSPs, manage validation efforts, and ensure rigorous compliance with CFR/ICH guidelines.

The role requires a Bachelor’s in life sciences with 8+ years in GMP QA, preferably in biotech or pharma, and readiness to travel 10-25% internationally.