Quality Associate, Batch Record Review and Product Disposition

Travere Therapeutics • San Diego, CA

2d • $85,000 - $105,000 • Onsite

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 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. 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.

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
• 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
• 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
• Good problem-solving skills, a 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

Nice To Haves

• Preference for candidates familiar and experienced with electronic document management systems and QMS such as Veeva or similar
• Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, implement improvements, and respond to situations affecting staff

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
• 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

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: Mid Level
• Education Level: No Education Listed