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Job description
Assist and support the monitoring and progression of technical documents through structured review and approval workflows
Work with cross-functional teams and use the Quality Management System (Veeva) for protocols and reports
Support validation documentation for manufacturing processes, test methods, supplier-change controls, manufacturing and laboratory investigations, CAPA, and effectiveness checks
Support data review for internal and external protocols, reports, and other documents
Assist with review and electronic QMS approval of interim stability reports
Cross-check regulatory submission data against approved source records and identify discrepancies
Develop and maintain knowledge of validation requirements, manufacturing processes, and analytical testing applicable to Travere products
Develop technical skills through knowledge sharing, training, coaching, and mentoring
Support QA with technical projects as needed
Collaborate with Travere’s cross-functional team to ensure contract vendors produce safe and effective products for clinical studies and commercial operations
Requirements
Bachelor’s degree in a life science or related field of study; equivalent combination of education and applicable job experience may be considered
5+ years of experience in quality working with solid oral drug and/or biologics in the biotechnology or pharmaceutical industry
5+ years of experience in GMP Quality Assurance, Qualification/Validation of Process and/or Test Methods or other applicable Quality Systems
Knowledge of electronic QMS systems; understanding of Veeva QMS is a plus
Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
Strong interpersonal and organizational skills
Excellent verbal and written communication skills
Problem-solving skills and ability to work independently
Ability to manage multiple priorities under time and resource pressures
Excellent technical writing, communication, and organizational skills
Strong attention to detail
Ability to travel 10% domestically and internationally
Ability to perform face-to-face work with colleagues and/or onsite in San Diego
Core Competencies
Demonstrates expertise in Quality Assurance and Validation processes within the biotechnology or pharmaceutical industry, with a strong focus on cGMP compliance and electronic Quality Management Systems. Proficient in technical writing and cross-functional collaboration to support product safety and effectiveness.
Highest-signal resume keywords
GMP Quality Assurance
Qualification/Validation of Process
Electronic QMS (Veeva)
Technical Writing
CGMP Knowledge
Hard Skills
Quality Management System
Validation Documentation
Manufacturing Processes
Test Methods
Regulatory Submission Data Review
Analytical Testing
CAPA
Effectiveness Checks
Data Review
Technical Skills Development
Soft Skills
Interpersonal Skills
Organizational Skills
Verbal Communication
Written Communication
Problem-Solving Skills
Attention to Detail
Industry Keywords
Biotechnology
Pharmaceutical
CGMP
CFR
ICH
Quality Systems
Solid Oral Drug
Biologics
Manufacturing Investigations
Supplier-Change Controls
Tools & Technologies
Veeva QMS
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.