Associate Director, Quality Assurance - Technical

Department: 107100 Quality Location: San Diego, USA- Remote 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 success. 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. 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. Education/Experience 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) an