Senior QA & Validation Specialist (GMP | Veeva QMS)

Jobtailor; San Diego (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Travere Therapeutics seeks a Quality Assurance/Validation professional to monitor and advance technical documentation within cGMP frameworks. You will engage with cross-functional teams and leverage Veeva QMS for protocols and reports, ensuring compliance across manufacturing and analytical activities.

The role requires 5+ years in GMP QA, strong technical writing skills, and the ability to travel up to 10% domestically and internationally. Onsite work in San Diego is expected.

Qualifications

• Bachelor’s degree in life science or related field.
• 5+ years in quality with solid oral drug or biologics.
• 5+ years in GMP QA, qualification/validation of processes or test methods.
• Knowledge of electronic QMS systems; Veeva QMS a plus.
• Broad knowledge of cGMPs CFR/ICH and international regs.
• Strong interpersonal and organizational skills.
• Excellent verbal and written communication.
• Problem-solving ability; able to work independently.
• Ability to manage multiple priorities under time/resource pressure.
• Willingness to travel 10% domestically/internationally.
• Onsite work in San Diego.

Responsibilities

• Assist and support monitoring and progression of technical documents through structured review and approval workflows.
• Work with cross-functional teams and use Veeva QMS for protocols and reports.
• Support validation documentation for manufacturing processes, test methods, supplier-change controls, manufacturing and laboratory investigations, CAPA, and effectiveness checks.
• Support data review for internal and 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 and identify discrepancies.
• Develop knowledge of validation requirements, manufacturing processes, and analytical testing.
• Develop technical skills through knowledge sharing, training, coaching, and mentoring.
• Support QA with technical projects as needed.
• Collaborate with cross-functional team to ensure contract vendors produce safe and effective products for clinical studies and commercial operations.

Skills

Quality Assurance

CFR/ICH Knowledge

Regulatory Knowledge

Technical Writing

Attention to Detail

Problem Solving

Cross-functional Collaboration

Verbal Communication

Written Communication

Travel Ability

Education

Bachelor’s degree in life science

Tools

Veeva QMS

Job description

Travere Therapeutics seeks a Quality Assurance/Validation professional to monitor and advance technical documentation within cGMP frameworks. You will engage with cross-functional teams and leverage Veeva QMS for protocols and reports, ensuring compliance across manufacturing and analytical activities.

The role requires 5+ years in GMP QA, strong technical writing skills, and the ability to travel up to 10% domestically and internationally. Onsite work in San Diego is expected.