Senior QA & Validation Specialist — Remote

Travere Therapeutics; Columbia (SC); Hybrid; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics, based in San Diego, is seeking a Senior Specialist, Quality Assurance Technical, to support qualification/validation for solid oral dose and biologics programs. The role collaborates with cross-functional teams to ensure regulatory compliance and product quality across clinical and commercial operations.

The ideal candidate will have 5+ years in GMP QA with experience in validation, QMS tools (Veeva preferred), and strong technical writing.

Qualifications

• Bachelor's degree in life science or related field.
• 5+ years of experience in quality with solid oral drug and/or biologics.
• 5+ years of GMP QA, qualification/validation or related Quality Systems.
• Knowledge of electronic QMS; Veeva QMS is a plus.

Responsibilities

• Assist with qualification/validation documents and product transfer activities.
• Review protocols, reports, and change controls in QMS.
• Support data review for internal and external protocols and stability reports.
• Cross-check regulatory submission data against source records.
• Develop knowledge of validation requirements and manufacturing processes.
• Mentor cross-functional team members and support technical projects.

Skills

Interpersonal skills

Organizational skills

Technical writing

Attention to detail

Education

Bachelor's degree in life science

Tools

Veeva QMS

Job description

Travere Therapeutics, based in San Diego, is seeking a Senior Specialist, Quality Assurance Technical, to support qualification/validation for solid oral dose and biologics programs. The role collaborates with cross-functional teams to ensure regulatory compliance and product quality across clinical and commercial operations.

The ideal candidate will have 5+ years in GMP QA with experience in validation, QMS tools (Veeva preferred), and strong technical writing.