Senior QA Validation Specialist - Remote

Travere Therapeutics

Boston (MA)

Hybrid

USD 95,000 - 124,000

Full time

6 days ago

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Benefits offered by this job

Premium health

Retirement plans with employer match

Generous paid time off

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. The role ensures quality and regulatory compliance across clinical and commercial operations.

The candidate will collaborate with cross-functional teams, manage review workflows in the QMS (Veeva), and contribute to data integrity and regulatory readiness while traveling up to 10% domestically

Qualifications

Bachelor's degree in a life science or related field; chemistry, biology, or chemical engineering preferred.
5+ years in quality with solid oral drug or biologics in biotech/pharma.
5+ years in GMP QA, qualification/validation or QA systems.
Knowledge of electronic QMS systems; Veeva QMS a plus.
Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsibilities

Assist with qualification/validation documents and product transfer activities.
Review data for internal and external protocols, reports, and documents.
Review interim stability reports and ensure QMS approvals.
Cross-check regulatory submission data against source records for discrepancies.
Develop knowledge of validation requirements and manufacturing processes.
Mentor cross-functional teammates and support QA projects.