Associate Director, QA Analytics & Compliance

Travere Therapeutics; New York (NY); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego seeks an Associate Director, Quality Assurance - Technical to lead GxP analytical QA support and oversee methods validation and transfer for both small and large molecules. You will collaborate with cross-functional teams and contract vendors for testing in clinical and commercial use.

The role requires 8+ years in analytical pharma/biotech with GMP/QA experience, CFR/ICH knowledge, and strong communication skills.

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 experience.
• Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsibilities

• Lead analytical qualification, validation, and transfer of analytical methods for small and large molecules.
• Review and oversee analytical validation activities including Protocols, Raw Data Review, and Validation Reports.
• Serve as primary contact for analytical questions with cross-functional groups and contract vendors.
• Provide SME in risk assessment to evaluate impact on product quality and mitigation recommendations.
• Support product stability program review and approval of protocols and reports.
• Support analytical data review for regulatory submissions.
• Contribute to Travere Policies and SOPs ensuring regulatory compliance.
• Maintain up-to-date knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
• Aid internal/external quality audits and inspections as needed.
• Support QA and senior management on various projects.

Skills

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Problem solving

Travel readiness

Education

Bachelor's degree in life science or related field

8+ years of experience in analytical function

GMP Knowledge

cGMP CFR/ICH knowledge

Job description

Travere Therapeutics in San Diego seeks an Associate Director, Quality Assurance - Technical to lead GxP analytical QA support and oversee methods validation and transfer for both small and large molecules. You will collaborate with cross-functional teams and contract vendors for testing in clinical and commercial use.

The role requires 8+ years in analytical pharma/biotech with GMP/QA experience, CFR/ICH knowledge, and strong communication skills.