Remote Senior IT Regulatory Systems Specialist

Vantive; Región Centro; Remote; MXN 600,000 - 900,000; Full time

Job summary

Vantive is a vital organ therapy company focusing on extending lives through digital solutions and innovative regulatory systems. The Sr Specialist, IT RA Global Apps will own regulatory applications, lead CSV validation, and collaborate with IT, QA, and business teams to ensure GxP compliance in a remote capacity.

The role requires strong technical foundations in Java/.NET/SQL, experience with Veeva/TrackWise/LIMS, and fluency in English and Spanish. Remote work is available across the country.

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, or related field.

Responsibilities

• Own and govern Quality & Regulatory IT applications, ensuring GxP, 21 CFR Part 11 and CSV compliance.
• Gather and document business requirements, translate into functional/technical specs.
• Lead CSV efforts, develop/execute validation plans and test scripts.
• Maintain documentation and ensure systems stay validated throughout lifecycle.
• Collaborate with IT, QA, regulatory and business stakeholders; support global IT projects.

Skills

Bilingual English and Spanish

Analytical Thinking

Communication

Attention to Detail

Problem Solving

Education

Bachelor’s degree in Computer Science/Information Systems

3+ years IT business analysis/validation in Life Sciences

Experience with CSV/GxP/21 CFR Part 11

SQL knowledge

Tools

Veeva Vault Platform

TrackWise

LabVantage LIMS

Veeva Vault QMS

Salesforce-based systems

Job description

Vantive is a vital organ therapy company focusing on extending lives through digital solutions and innovative regulatory systems. The Sr Specialist, IT RA Global Apps will own regulatory applications, lead CSV validation, and collaborate with IT, QA, and business teams to ensure GxP compliance in a remote capacity.

The role requires strong technical foundations in Java/.NET/SQL, experience with Veeva/TrackWise/LIMS, and fluency in English and Spanish. Remote work is available across the country.