Senior Quality Specialist, Technical

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

• 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

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.

• GMP Quality Assurance
• Qualification/Validation of Process
• Electronic QMS (Veeva)
• Technical Writing
• CGMP Knowledge

• Quality Management System
• Validation Documentation
• Manufacturing Processes
• Test Methods
• Regulatory Submission Data Review
• Analytical Testing
• CAPA
• Effectiveness Checks
• Data Review
• Technical Skills Development

• Interpersonal Skills
• Organizational Skills
• Verbal Communication
• Written Communication
• Problem-Solving Skills
• Attention to Detail

• Biotechnology
• Pharmaceutical
• CGMP
• CFR
• ICH
• Quality Systems
• Solid Oral Drug
• Biologics
• Manufacturing Investigations
• Supplier-Change Controls

• Veeva QMS