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, with work that is both professionally and personally rewarding. We are passionate about what we do and seek talented individuals who thrive in a collaborative, diverse, and fast-paced environment while sharing our mission to identify, develop, and deliver life-changing therapies.

About the role

The Associate Director, Quality Assurance - Technical, leads and provides GxP Analytical quality and compliance support and oversight as per requirements and applicable guidance. This role works closely with cross-functional teams and contract vendors for testing product 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 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 appropriately assess impact on product quality and support mitigation recommendations.
• Support the product stability program with review and approval of protocols, interim reports, raw data review, and final reports.
• Support the analytical review of data for regulatory submissions.
• Provide technical input to Travere policies, SOPs, work instructions, etc., 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, and USP).
• Aid in internal and external Quality audit functions as needed.
• Provide support and contribute to 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, or 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 functions.
• Strong interpersonal, organizational, verbal, and written communication skills.
• Adept problem-solving skills, 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 cash (base pay and short-term incentive) and long-term incentive compensation (company stock).