Senior QA Specialist - Rare Disease (Remote)

Travere Therapeutics; Manchester (NH); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health

Work-life and well-being offerings

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior Specialist in Quality Assurance Technical to support qualification/validation activities for solid oral dose and biologic programs. The role ensures quality and compliance with regulatory requirements across clinical and ongoing operations.

The position collaborates with cross-functional teams to ensure products from vendors meet Travere standards. A strong background in GMP QA, QMS, and regulatory knowledge is essential for success.

Qualifications

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

Responsibilities

• Assist with monitoring and progression of technical docs through reviews in the Quality Management System (Veeva).
• Support validation protocols and change controls related to supplier changes.
• Review investigations, CAPA and effectiveness checks; support data review for protocols and reports.
• Review interim stability reports and ensure regulatory submission data integrity.
• Develop knowledge of validation requirements and manufacturing/analytical testing relevant to Travere products.
• Collaborate cross-functionally to mentor teammates and support various QA projects.

Skills

Quality Assurance

GMP

Veeva QMS

cGMPs (CFR/ICH)

Education

Bachelor's degree in life science

Tools

Veeva QMS

Job description

Travere Therapeutics is seeking a Senior Specialist in Quality Assurance Technical to support qualification/validation activities for solid oral dose and biologic programs. The role ensures quality and compliance with regulatory requirements across clinical and ongoing operations.

The position collaborates with cross-functional teams to ensure products from vendors meet Travere standards. A strong background in GMP QA, QMS, and regulatory knowledge is essential for success.