Senior Quality Specialist - Remote, Pharma QA & Validation

Travere Therapeutics; United States; On-site; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation activities for solid oral dose and biologics programs, ensuring quality and regulatory compliance across clinical and commercial stages.

The role involves cross-functional collaboration, review of validation docs, change controls, data review, and QMS approvals. Strong QA background with cGMP and Veeva QMS is essential.

Qualifications

• Bachelor’s degree in a life science or related field.
• 5+ years of experience in quality working with solid oral drug and/or biologics.
• 5+ years of GMP Quality Assurance, Qualification/Validation or related Quality Systems.
• Knowledge of electronic QMS systems; Veeva QMS a plus.
• Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsibilities

• Assist and support qualification/validation documents and product transfer activities.
• Review and approve protocols and reports for validation of manufacturing processes and test methods.
• Manage change controls related to supplier changes.
• Support data review for internal/external protocols and reports.
• Review interim stability reports and QA approvals in the QMS.
• Cross-check regulatory submission data against source records for discrepancies.
• Develop knowledge of validation requirements and applicable processes.
• Mentor cross-functional team members and support QA projects.

Skills

QA Knowledge

Documentation

Veeva QMS

cGMPs CFR/ICH

Regulatory Knowledge

Communication

Problem Solving

Education

Bachelor’s in Life Science

Tools

Veeva QMS

Job description

Travere Therapeutics in San Diego, CA, seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation activities for solid oral dose and biologics programs, ensuring quality and regulatory compliance across clinical and commercial stages.

The role involves cross-functional collaboration, review of validation docs, change controls, data review, and QMS approvals. Strong QA background with cGMP and Veeva QMS is essential.