Senior QA Specialist, Validation & Tech Transfer — Remote

Travere Therapeutics; Washington (District of Columbia); Hybrid; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics is seeking a Senior Specialist, Quality Assurance Technical, to support qualification/validation docs and product transfer activities for solid oral dose and biologic programs. This role ensures quality and regulatory compliance for Travere products produced by contract vendors during clinical studies and commercial operations.

The successful candidate will work with cross-functional teams, maintain QMS documentation, and uphold cGMP standards while traveling up to 10%

Qualifications

• Bachelor's degree in a life science or related field; Chemistry/Biology/Chemical Engineering preferred.
• 5+ years of quality experience in solid oral drug and/or biologics.
• Knowledge of electronic QMS systems; Veeva QMS a plus; broad knowledge of cGMPs (CFR/ICH).

Responsibilities

• Assist and support monitoring of technical documents through review/workflows using the QMS (Veeva).
• Support data review for internal/external protocols and reports.
• Assist with review and electronic QMS approval of interim stability reports.
• Cross check regulatory submission data against source records for discrepancies.
• Develop and maintain knowledge of validation requirements and manufacturing/analytical testing for Travere products.
• Mentor cross-functional team members to support professional development.
• Support QA with various technical projects as needed.

Skills

Interpersonal skills

Organizational skills

Communication

Problem solving

Attention to detail

Travel readiness

Education

Bachelor's degree in life sciences or related field

5+ years QA GMP experience

Knowledge of QMS (Veeva a plus)

Job description

Travere Therapeutics is seeking a Senior Specialist, Quality Assurance Technical, to support qualification/validation docs and product transfer activities for solid oral dose and biologic programs. This role ensures quality and regulatory compliance for Travere products produced by contract vendors during clinical studies and commercial operations.

The successful candidate will work with cross-functional teams, maintain QMS documentation, and uphold cGMP standards while traveling up to 10%