Quality Associate, Batch Record Review and Product Disposition

Department:

Location:

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 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 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:

• Bachelors degree in life science or related field of study . Equivalent combination of education and applicable job experience may be considered

• 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 Traveres 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: 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:

*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 candidates 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 . 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.