Senior QA Director, Analytical – Remote

Travere Therapeutics; Denver (CO); On-site; 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 and provide oversight across analytical methods for small and large molecules. You will collaborate with cross‑functional teams and contract vendors for testing in clinical and commercial contexts.

The role requires a Bachelor’s degree in life sciences and 8+ years in analytical QA, with strong knowledge of cGMPs and regulatory expectations.

Qualifications

• Bachelor's degree in life science or related field required; sciences 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 and support analytical qualification, validation, and transfer of analytical methods for small and large molecules.
• Review, approve and/or oversee various aspects of analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, Test methods).
• Serve as the primary point of contact for cross-functional groups and contract vendors for analytical questions, issues and resolutions (Laboratory Deviations, OOS/OOT Results, Change Controls, CAPA).
• Provide SME in aiding risk assessment to assess impact on product quality and mitigation recommendations.
• Support product stability program with review/approval of protocols, interim/final reports and data review.
• Support analytical review of data for regulatory submissions.
• Provide input to policies/SOPs and ensure regulatory compliance.
• Maintain up-to-date knowledge of regulatory requirements (FDA, ICH, EMA, USP).
• Assist internal and external QA audits and inspections as needed.
• Support Senior Management with various projects.

Skills

GxP Analytical

Quality Assurance

Analytical Method Validation

cGMP CFR/ICH knowledge

Regulatory Submissions

Problem Solving

Communication Skills

Travel Readiness

Education

Bachelor's degree in life science or related field

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical, to lead GxP analytical quality/compliance and provide oversight across analytical methods for small and large molecules. You will collaborate with cross‑functional teams and contract vendors for testing in clinical and commercial contexts.

The role requires a Bachelor’s degree in life sciences and 8+ years in analytical QA, with strong knowledge of cGMPs and regulatory expectations.