Senior QA Assurance Director, Analytical (Remote)

Travere Therapeutics; Columbia (SC); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking an Associate Director, Quality Assurance - Technical to lead GxP analytical quality/compliance and collaborate with cross-functional teams and external vendors for clinical and commercial testing.

The role requires 8+ years in analytical functions in biotech/pharma, GMP QA experience, and strong regulatory knowledge. It entails supporting stability programs, regulatory submissions, and QA policy development, with travel up to 10-20%.

Qualifications

• Bachelor's degree in life science or related field required.
• 8+ years of experience in an analytical function in biotech/pharma.
• Direct experience in GMP Quality Assurance, Analytical Qualification/Validation and/or Quality Systems.
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations.

Responsibilities

• Lead and provide GxP analytical quality/compliance support and oversight.
• Coordinate analytical qualification, validation and transfer of analytical methods.
• Oversee qualification/validation activities (method validation, raw data review, reports).
• Act as primary contact for cross-functional groups and vendors for analytical issues.
• Support stability programs, regulatory submissions, and QA policies.
• Assist with internal/external audits, inspections and due diligence.

Skills

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Communication skills

Problem-solving

Attention to detail

Time management

Travel readiness

Education

Bachelor's degree in life science or related field

Job description

Travere Therapeutics in San Diego is seeking an Associate Director, Quality Assurance - Technical to lead GxP analytical quality/compliance and collaborate with cross-functional teams and external vendors for clinical and commercial testing.

The role requires 8+ years in analytical functions in biotech/pharma, GMP QA experience, and strong regulatory knowledge. It entails supporting stability programs, regulatory submissions, and QA policy development, with travel up to 10-20%.