Quality Associate, Batch Record Review and Product Disposition

Quality AssociateBe 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 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. This position also supports continual process improvement for Quality Management Systems.Primary Responsibilities :Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device productsPerform 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 to meet clinical and commercial production timelinesCollaborate closely with Technical Operations and Clinical Operations Personnel responsible for Manufacturing, Labeling, Packaging, Batch Kitting, and DistributionSupport QA Supplier Management and Oversight of Contract Manufacturing Organizations (CMOs) starting with Phase 2 Clinical Trials through marketed products, and in all situations where GMP Batches are requiredManage assigned SOPs revisions and quality records (CAPAs, Deviations, Investigations, Product Complaints, Audit Responses, Change Controls, & Trainings) to ensure timely completion for the organization and associated department(s)Participates in supplier meetings, managing production timelines with batch release activitiesSupport products for clinical development and commercial production including Oral Drugs, Biologics, and Combination ProductsProvides daily oversight of quality systems records including, CAPAs, Deviations, Investigations, Batch Record Review, and Change ControlsSupport revision of the existing SOP(s) and Work Instructions related to assigned duties to help define a clear and accurate processAdditional Responsibilities :Support audit program activities for internal, external, mock, and regulatory auditsProvide quality and compliance oversight and act as a SME for the Quality Systems at Travere including, but not limited to:Veeva Quality Vault (QualityDocs and QMS)Document ManagementQuality Events (Complaints, Deviations, Audit Findings, Change Controls)Quality Actions (Audits, CAPAs, Effectiveness Checks, Investigations, Root Causes)Quality MetricsEnsure documentation in support of regulatory submissions is uploaded in QualityDocs appropriatelyOversee the creation, revision, review, and approval of GxP controlled documents (e.g., SOPs, WINs, Forms) and recordsAdditional duties assigned as neededEducation/Experience Requirements:Minimum of 2-3 years of experience in QA batch record review and leading QA oversight of Contract Manufacturing Organizations (CMOs)Quality Assurance (QA) experience with Manufacturing, Laboratories, Logistics, CMOs, Distributors, and Warehouses is preferredAdditional Skills/Experience:The ideal candidate will embody Travere's core values: Patient Inspired, Promoting Community, Courageous, and Stronger TogetherBroad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelinesPreference for candidates familiar and experienced with electronic document management systems and QMS such as Veeva or similarStrong professional experience in a similar role within the pharmaceutical industry, providing supplier management support for pharmaceutical, medical device, or combination productsWell organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional environmentStrong interpersonal and organizational skills and excellent verbal and written communication skills are requiredPrefer but not required: Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, implement improvements, and respond to situations affecting staffGood 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 pressuresExcellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexitySuccessful record of creating and managing complex project plans, timelines, budgets, and critical pathsAbility to adapt to changes to priorities, demonstrating flexibility to implement new strategies and tactics to accommodate these changesExperience with regulatory inspectionsAll positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remoteAbility to travel 10-20% domestically and internationallyTotal Rewards Offerings: Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.Benefits: Our benefits include 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 and generous paid time off.Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.Target Base Pay Range:$85,000.00 - $105,000.00*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.Travere will accept applications on an ongoing basis until a candidate is selected for the position.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 us by sending an email to View email address on click.appcast.io. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.