Associate Director, Quality Assurance - Technical

Be part of a global team inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients, delivering rewarding professional and personal experiences. Our work is driven by passion and a shared mission—to identify, develop, and deliver life-changing therapies.

We uphold values centered on patients, courage, community, and collaboration, pursuing our vision of becoming a leading biopharmaceutical company dedicated to innovation and hope for the global rare disease community.

About the role

The Associate Director, Quality Assurance - Technical, leads and provides GxP Analytical quality and compliance support and oversight in alignment with applicable requirements and guidance. This role collaborates closely with cross-functional teams and contract vendors for testing product intended for clinical and commercial use.

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, including:
  • Method Validation Protocol
  • Raw Data Review
  • Method Validation Report
  • Test methods
• Serve as the primary point of contact for Travere cross-functional groups and contract vendors for analytical questions, issues, and resolution of:
  • Laboratory Deviations
  • Out of Specification / Out of Trend Results
  • Change Controls
  • CAPA
• Provide subject matter expertise in risk assessment activities to evaluate impact on product quality and support mitigation recommendations.
• Support the product stability program through review and approval of protocols, interim reports, raw data, and final reports.
• Support analytical review of data for regulatory submissions.
• Provide technical input to Travere policies, SOPs, work instructions, ensuring compliance with regulatory requirements, guidance, and industry standards.
• Maintain up-to-date knowledge of analytical regulatory requirements, practices, and processes (e.g., FDA, ICH, EMA, USP).
• Aid in internal and external Quality audit functions as needed.
• Support inspections, audits, and due diligence activities.
• Support QA and Senior Management with various projects as needed.

Requirements

• Bachelor’s degree in life science or a related field (e.g., Chemistry, Biology, Chemical Engineering) required. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of experience in an analytical function supporting drug/biologics development and commercialization in the biotechnology or pharmaceutical industry.
• 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.

Skills

• Embodies Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Demonstrated ability to critically assess and analyze information, draw technical conclusions, and influence approaches across internal and external functions.
• Strong interpersonal, organizational, verbal, and written communication skills.
• Adept problem-solving skills, sense of urgency, attention to detail, and ability to work independently while managing multiple priorities under time and resource pressures.
• Ability to travel up to 10-20% domestically and internationally.
• All positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is 100% remote.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Pay

Target base pay range: $150,000.00 – $195,000.00. Actual pay offered will depend on experience, education, skills, and location. The compensation package includes a combination of base pay, short-term incentives, and long-term incentives (company stock).