Senior QA Validation Lead – Remote Biotech

Travere Therapeutics; Providence (RI); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plan with employer match

Generous paid time off

Life insurance

Disability insurance

Job summary

Travere Therapeutics in San Diego, CA is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologics programs, ensuring quality and regulatory compliance.

You will collaborate with cross-functional teams, review and approve technical documents in the QMS (Veeva), and help maintain validation knowledge while guiding junior staff toward professional growth. Travel 10% is expected.

Qualifications

• Bachelor's degree in a life science or related field.
• 5+ years of QA experience in solid oral drug and/or biologics.
• 5+ years of GMP QA, qualification/validation or related quality systems.
• Knowledge of electronic QMS systems; Veeva QMS a plus.
• Broad knowledge of cGMPs (CFR/ICH) and international guidelines.

Responsibilities

• Assist with qualification/validation documents and product transfer activities.
• Review and approve technical documents in QMS workflows (Veeva).
• Support data reviews for protocols, reports and other documents.
• Cross-check regulatory submission data against source records.
• Develop knowledge of validation requirements and manufacturing processes.
• Mentor cross-functional team members to support professional development.
• Support QA with various technical projects as needed.

Skills

Quality Assurance

GMP

Veeva QMS

Documentation Review

Regulatory Compliance

Education

Bachelor's degree in life science

Tools

Veeva QMS

Job description

Travere Therapeutics in San Diego, CA is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologics programs, ensuring quality and regulatory compliance.

You will collaborate with cross-functional teams, review and approve technical documents in the QMS (Veeva), and help maintain validation knowledge while guiding junior staff toward professional growth. Travel 10% is expected.