Analytical QA Leader – Drug Development (Remote)

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

Job summary

Travere Therapeutics in San Diego is seeking an Associate Director of Quality Assurance - Technical to lead GxP analytical quality and compliance across development and commercialization stages. You will collaborate with cross-functional teams and vendors to qualify, validate, and transfer analytical methods, review validation activities, and support regulatory submissions.

The role requires deep GMP knowledge, risk assessment, and readiness for 10-20% travel; on-site presence in San Diego is

Qualifications

• Bachelor's degree in life science or related field is required.
• At least 8 years of analytical experience in biotech/pharma.

Responsibilities

• Lead analytical qualification, validation and transfer of analytical methods for small and large molecules.
• Review and oversee analytical validation activities including method validation protocols and data review.
• Serve as primary contact for cross-functional teams and vendors on analytical questions and deviations.
• Provide SME in risk assessment to evaluate impact on product quality and Mitigation recommendations.
• Support stability programs with protocol review and data assessment.
• Support data review for regulatory submissions.
• Contribute to QA policies, SOPs, and regulatory compliance.
• Maintain up-to-date knowledge of regulatory requirements (FDA, ICH, EMA, USP).
• Support audits, inspections, and due diligence as needed.
• Travel up to 10-20% domestically and internationally.

Skills

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Strong communication skills

Travel readiness

Education

Bachelor's degree in life science or related field

8+ years in analytical function in biotech/pharma

Experience with GMP/Quality Systems

Job description

Travere Therapeutics in San Diego is seeking an Associate Director of Quality Assurance - Technical to lead GxP analytical quality and compliance across development and commercialization stages. You will collaborate with cross-functional teams and vendors to qualify, validate, and transfer analytical methods, review validation activities, and support regulatory submissions.

The role requires deep GMP knowledge, risk assessment, and readiness for 10-20% travel; on-site presence in San Diego is