Associate Director, QA & Analytical Compliance (Remote)

Travere Therapeutics; Manchester (NH); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical, to lead GxP analytical quality/compliance activities for clinical and commercial testing. You will partner with cross-functional teams and contract vendors to ensure rigorous analytical qualification, validation, transfer, and data review in accordance with FDA, ICH, EMA, and USP standards.

The role requires strong analytical QA experience, the ability to review complex data, and effective communication across

Qualifications

• Bachelor's degree in life science or related field is required.
• 8+ years of experience in an analytical function supporting drug/biologics development and commercialization in biotech/pharma.
• 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 and support analytical qualification, validation, and transfer of analytical methods for small and large molecules.
• Review, approve and/or oversee analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, Test methods).
• Serve as primary contact for cross-functional groups and contract vendors on deviations, OOS/OOT, Change Controls, CAPA.
• Provide SME input for risk assessment and mitigation related to product quality.
• Support stability program with protocol reviews and data approval.
• Support analytical data review for regulatory submissions.
• Provide input to policies and SOPs to ensure regulatory compliance.
• Maintain knowledge of regulatory requirements (FDA, ICH, EMA, USP).
• Assist with internal/external quality audits, inspections and due diligence.

Education

Bachelor's degree in life science or related field

Tools

GxP QA tools

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical, to lead GxP analytical quality/compliance activities for clinical and commercial testing. You will partner with cross-functional teams and contract vendors to ensure rigorous analytical qualification, validation, transfer, and data review in accordance with FDA, ICH, EMA, and USP standards.

The role requires strong analytical QA experience, the ability to review complex data, and effective communication across