Quality Associate, Batch Record Review and Product Disposition

Position Summary The Quality Associate supports Quality Operations through the quality oversight of Manufacturing, Packaging, and Labeling Operations, batch record review, product disposition, clinical and commercial supplier management oversight, quality records management, and GxP metrics reporting. This position supports completion of inspection readiness action items and provides compliance support for the quality systems at Travere Therapeutics, Inc. and key suppliers. It also supports continual process improvement for quality management systems. Primary Responsibilities Support QA batch record review, product disposition, and supplier management for small molecule, biologics, and device products. Perform QA batch review and approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition. Collaborate closely with Technical Operations and Clinical Operations personnel responsible for manufacturing, labeling, packaging, batch kitting, and distribution support. Manage QA supplier oversight of contract manufacturing organizations from Phase 2 clinical trials through marketed products and in all situations where GMP batches are required. Manage assigned SOP revisions and quality records (CAPAs, deviations, investigations, product complaints, audit responses, change controls, and trainings) to ensure timely completion. Participate in supplier meetings, managing production timelines with batch release activities. Support products for clinical development and commercial production, including oral drugs, biologics, and combination products. Provide daily oversight of quality systems records including CAPAs, deviations, investigations, batch record review, and change controls. Support revision of existing SOPs and work instructions related to assigned duties to help define a clear and accurate process. Additional Responsibilities Support audit program activities for internal, external, mock, and regulatory audits. Provide quality and compliance oversight and act as SME for the quality systems at Travere, including Veeva Quality Vault (QualityDocs and QMS) document management, quality events, actions, and metrics. Ensure documentation in support of regulatory submissions is uploaded in QualityDocs appropriately. Oversee the creation, revision, review, and approval of GxP controlled documents (SOPs, WINs, forms). Additional duties as assigned. Education and Experience Requirements Minimum of 2–3 years of experience in QA batch record review and leading QA oversight of contract manufacturing organizations. QA experience with manufacturing, laboratories, logistics, CMOs, distributors, and warehouses is preferred. Additional Skills and Experience Broad knowledge of cGMPs and applicable international regulations and guidelines. Familiarity with electronic document management systems and QMS such as Veeva. Strong professional experience in a similar role within the pharmaceutical industry, providing supplier management support for pharmaceutical, medical device, or combination products. Well organized, able to multitask, prioritize, and manage shifting responsibilities. Excellent verbal and written communication skills. Good problem‑solving skills, strong sense of urgency, keen attention to detail. Ability to work independently and manage multiple priorities under time and resource pressures. Successful record of creating and managing complex project plans, timelines, budgets, and critical paths. Ability to adapt to changes and demonstrate flexibility. Experience with regulatory inspections. Previous line management experience is a plus but not required. Travel and Work Location All positions require face‑to‑face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote. Ability to travel 10–20% domestically and internationally. Compensation and Benefits Target base pay range: $85,000 – $105,000. Compensation includes base pay, short‑term incentive, and long‑term incentive (company stock). Benefits include premium health, financial, work‑life and well‑being offerings, life insurance, disability, retirement plans with employer match, and generous paid time off. Equal Employment Opportunity Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. If you require a reasonable accommodation to complete the application or interview process, please contact View email address on click.appcast.io. #J-18808-Ljbffr