Associate Director, Quality Assurance - Technical

Travere • San Diego, CA

4d • Hybrid

About The Position

Be a part of a global team that is 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 Поэтому. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: The Associate Director, Quality Assurance - Technical, is responsible for leading and providing GxP Analytical quality/compliance support and/or oversight as per requirements and applicable guidance. This role works closely with the cross functional Travere team and Travere’s contract vendors for testing of product for clinical and commercial use.

Requirements

• Bachelor’s degree in life science or related field of study required. A relevant technical or scientific field, Chemistry, Biology, or Chemical Engineering is preferred. 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 required.
• 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.

Nice To Haves

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Demonstrated ability to critically assess/analyze information, draw the appropriate technical conclusions based upon system knowledge, influence approach, and work effectively across different internal and external functions to resolve complex technical quality issues.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Adept problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.

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 but not limited to: 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 aiding risk assessment activities to appropriately assess the impact on product quality while supporting mitigation recommendations for the above.
• Support product(s) 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 Polices, SOPs, Work Instructions, etc., assuring internal needs are defined while complying with Regulatory requirements, Guidance and/or industry standards
• Maintain up-to-date knowledge of analytical regulatory requirements, practices, and processes (ex. FDA, ICH, EMA, and USP requirements).
• Aid in the internal and external Quality audit function, as needed
• Provide support and contribute to inspections, audits and due diligence activities as needed.
• Support QA and Travere Senior Management with various projects as needed.

Benefits

• premium health, financial, work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Manager