Remote Associate Director, Quality Assurance (Analytical)

Travere Therapeutics; Atlanta (GA); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA invites a seasoned Associate Director, Quality Assurance - Technical to lead GxP analytical quality activities for clinical and commercial programs. You will partner with cross-functional teams and external vendors to qualify, validate and transfer analytical methods for small and large molecules, ensure data integrity, and support regulatory submissions.

The role requires a strong background in GMP, CFR/ICH, and quality systems, plus 8+ years in

Qualifications

• Bachelor's degree in life science or related field required.
• 8+ years of analytical experience in biotech/pharma.
• Direct GMP QA, Analytical Qualification/Validation and Quality Systems experience.
• Broad knowledge of cGMPs CFR/ICH and international guidelines.

Responsibilities

• Lead analytical qualification, validation, and transfer of methods for small and large molecules.
• Review/oversee analytical validation activities (protocols, raw data, reports, test methods).
• Serve as primary contact for analytical questions with cross-functional groups and vendors.
• Provide risk assessment input and mitigation recommendations for product quality.

Skills

GxP Analytical QA

Cross-functional teamwork

Communication skills

Travel availability

Education

Bachelor's degree in life science

Tools

GMP CFR/ICH knowledge

Analytical validation tools

Job description

Travere Therapeutics in San Diego, CA invites a seasoned Associate Director, Quality Assurance - Technical to lead GxP analytical quality activities for clinical and commercial programs. You will partner with cross-functional teams and external vendors to qualify, validate and transfer analytical methods for small and large molecules, ensure data integrity, and support regulatory submissions.

The role requires a strong background in GMP, CFR/ICH, and quality systems, plus 8+ years in