Senior Regulatory IT Lead for RIM Systems

Vantive; Dolores Hidalgo; A distancia; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Vantive is seeking a Sr Specialist, IT RA Global Apps to own and govern Regulatory IT applications, ensuring CSV, GxP, and 21 CFR Part 11 compliance. You will gather requirements, design solutions, and lead validation, testing, and change control in a regulated environment.

You’ll collaborate with IT and business teams to deploy configurable solutions in Veeva, TrackWise, and LabVantage, while ensuring they remain validated and scalable across global Quality and Regulatory programs.

Formación

• Bachelor’s degree in Computer Science, Information Systems, or a related field.
• 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry.
• Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications.
• Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance.
• Ability to develop and execute test scripts, validation plans, and system documentation.
• Technical knowledge of SQL, system integrations, and application configuration.
• Spanish and English speaking and written communication skills are mandatory.

Responsabilidades

• Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and CSV requirements.
• Implement solutions that align with business needs and regulatory requirements.
• Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records.
• Ensure systems remain in a validated state throughout their lifecycle.
• Gather, analyze, and document business requirements, workflows, and process improvements.
• Translate business needs into functional and technical specifications.
• Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.
• Ensure solutions are scalable, compliant, and aligned with Vantive’s digital transformation strategy.
• Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards.
• Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes.
• Manage risk assessments, audits, and regulatory inspections related to system validation and compliance.
• Oversee system upgrades, patches, and maintenance, recommending enhancements as needed.
• Manage issue triage, root cause analysis, and resolution for system defects.
• Coordinate with vendors and internal teams for system support and enhancements.
• Act as a key liaison between IT, Quality, Regulatory, and business stakeholders.
• Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives.
• Provide end-user training and support, ensuring smooth adoption of system enhancements.
• Assist with project management tasks, ensuring timely delivery of IT solutions.

Conocimientos

Java

.NET

SQL

Cloud

GxP

Regulatory knowledge

Business analysis

Stakeholder management

Educación

Bachelor’s degree in Computer Science or Information Systems

Herramientas

Veeva Vault QMS

TrackWise

LabVantage LIMS

Descripción del empleo

Vantive is seeking a Sr Specialist, IT RA Global Apps to own and govern Regulatory IT applications, ensuring CSV, GxP, and 21 CFR Part 11 compliance. You will gather requirements, design solutions, and lead validation, testing, and change control in a regulated environment.

You’ll collaborate with IT and business teams to deploy configurable solutions in Veeva, TrackWise, and LabVantage, while ensuring they remain validated and scalable across global Quality and Regulatory programs.