Associate Director, QA Analytics & Validation (Remote)

Travere Therapeutics; Columbus (OH); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego (remote) seeks an Associate Director, Quality Assurance - Technical to lead GxP analytical quality/compliance and oversee testing for clinical and commercial use. You will collaborate with cross-functional teams and external vendors to ensure data integrity and regulatory readiness.

The role requires 8+ years in analytical functions within biotech/pharma, strong knowledge of cGMPs, and experience with validation, transfer, and quality systems.

Qualifications

• Bachelor's degree in life science or related field required; chemistry/biology/engineering preferred.
• 8+ years of experience in an analytical function supporting drug/biologics development and commercialization.
• Direct experience in GMP Quality Assurance, Analytical Qualification/Validation and/or Quality Systems.
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.

Responsibilities

• Lead analytical qualification, validation, and transfer of analytical methods for small and large molecules.
• Review/oversee analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, Test methods).
• Serve as primary contact for analytical questions with cross-functional teams and vendors (Deviation, OOS/OOT, Change Controls, CAPA).
• Provide SME in risk assessment to assess impact on product quality and mitigation recommendations.
• Support product stability program review/approval of protocols and reports.
• Support analytical data reviews for regulatory submissions.
• Provide input to policies, SOPs, and work instructions ensuring regulatory compliance.
• Maintain up-to-date knowledge of FDA/ICH/EMA/USP requirements.
• Aid internal/external quality audits and inspections.
• Support QA and senior management with various projects.

Skills

GxP Quality

Analytical QA

cGMP CFR/ICH

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in life science

8+ years experience in analytical function

Job description

Travere Therapeutics in San Diego (remote) seeks an Associate Director, Quality Assurance - Technical to lead GxP analytical quality/compliance and oversee testing for clinical and commercial use. You will collaborate with cross-functional teams and external vendors to ensure data integrity and regulatory readiness.

The role requires 8+ years in analytical functions within biotech/pharma, strong knowledge of cGMPs, and experience with validation, transfer, and quality systems.