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. 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 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 to meet clinical and commercial production timelines
• Collaborate closely with Technical Operations and Clinical Operations Personnel responsible for Manufacturing, Labeling, Packaging, Batch Kitting, and Distribution
• Support 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 required
• Manage 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 activities
• Support products for clinical development and commercial production including Oral Drugs, Biologics, and Combination Products
• Provides daily oversight of quality systems records including, CAPAs, Deviations, Investigations, Batch Record Review, and Change Controls
• Support revision of the existing SOP(s) 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 a SME for the Quality Systems at Travere including, but not limited to:
• Veeva Quality Vault (QualityDocs and QMS)
• Document Management
• Quality Events (Complaints, Deviations, Audit Findings, Change Controls)
• Quality Actions (Audits, CAPAs, Effectiveness Checks, Investigations, Root Causes)
• Quality Metrics
• Ensure documentation in support of regulatory submissions is uploaded in QualityDocs appropriately
• Oversee the creation, revision, review, and approval of GxP controlled documents (e.g., SOPs, WINs, Forms) and records
• Additional duties assigned as needed

Education/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 preferred

Additional Skills/Experience:

• The ideal candidate will embody Travere’s core values: Patient Inspired, Promoting Community, Courageous, and Stronger Together
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
• Preference for candidates familiar and experienced with electronic document management systems and QMS such as Veeva or similar
• Strong professional experience in a similar role within the pharmaceutical industry, providing supplier management support for pharmaceutical, medical device, or combination products
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional environment
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
• Prefer 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 staff
• Good 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
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths
• Ability to adapt to changes to priorities, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
• Experience with regulatory inspections
• All 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% remote
• Ability to travel 10-20% domestically and internationally

Total Rewards Offerings :

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

_Benefits:_

_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.