Remote Senior QA Specialist, Validation & Compliance

Travere Therapeutics; Detroit (MI); On-site; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologic programs. This role ensures quality and regulatory compliance across clinical and commercial operations.

The candidate will collaborate with cross-functional teams, review technical documents, and assist with stability reports within a QMS framework.

Qualifications

• Bachelor's degree in life sciences or related field; equivalent combo with experience considered.
• 5+ years in GMP QA for solid oral drugs/biologics; strong QA systems experience.
• Knowledge of electronic QMS; Veeva QMS familiarity is a plus.
• Broad knowledge of cGMPs CFR/ICH and international regs.

Responsibilities

• Assist and monitor technical documents through structured reviews in the QMS (Veeva).
• Support data review for internal/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.
• Develop and maintain knowledge of validation requirements, manufacturing and analytics.
• Mentor cross-functional team members and support QA projects.

Skills

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Problem-solving

Attention to detail

Travel readiness

Education

Bachelor's degree in life science or related field

Tools

Veeva QMS

Job description

Travere Therapeutics is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologic programs. This role ensures quality and regulatory compliance across clinical and commercial operations.

The candidate will collaborate with cross-functional teams, review technical documents, and assist with stability reports within a QMS framework.