Associate Director, Analytical QA — Remote

Travere Therapeutics; Minneapolis (MN); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with employer match

Stock-based compensation

Paid time off

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical in San Diego. The role leads GxP analytical quality support, partnering with cross-functional teams and vendors on method validation, deviations, CAPA, and data reviews for regulatory submissions and product quality.

You will provide SME input on risk assessment, support stability programs, audits, and inspections while keeping current with FDA/ICH/EMA guidelines and ensuring compliance.

Qualifications

• Bachelor's degree in life science or related field; equivalent combination may be considered.
• 8+ years of experience in an analytical function in biotech/pharma.
• Direct GMP QA experience and knowledge of CFR/ICH.
• Broad knowledge of cGMPs and international regulations.

Responsibilities

• Lead analytical qualification/validation and transfer of analytical methods.
• Review and oversee analytical validation activities and reports.
• Be the primary contact for analytical questions with cross-functional teams and vendors.
• Support risk assessment and mitigation related to product quality impact.
• Assist with stability programs, regulatory submissions, and QA policies.

Skills

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Attention to detail

Written communication

Education

Bachelor's degree life sciences

Tools

GxP systems

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical in San Diego. The role leads GxP analytical quality support, partnering with cross-functional teams and vendors on method validation, deviations, CAPA, and data reviews for regulatory submissions and product quality.

You will provide SME input on risk assessment, support stability programs, audits, and inspections while keeping current with FDA/ICH/EMA guidelines and ensuring compliance.