Senior IT Specialist, Regulatory Systems – Veeva RIM

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Take ownership and manage Quality and Regulatory IT applications.

• Act as a functional business analyst by collecting and analyzing business requirements and defining specifications.

• Design and implement configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.

• Lead system validation, testing execution, and change management in a regulated setting.

• Ensure compliance with GxP, 21 CFR Part 11, CSV, FDA, ISO 13485, and international regulatory standards.

• Maintain functional specifications, design documents, validation strategies, and change control records.

• Guarantee that systems remain in a validated state throughout their entire lifecycle.

• Develop and execute test scripts, UAT scenarios, and validation strategies.

• Manage risk assessments, audits, and regulatory inspections concerning validation and compliance.

• Oversee system upgrades, patches, maintenance, defect triage, root cause analysis, and resolution of issues.

• Serve as a liaison between IT, Quality, Regulatory, business process owners, and external vendors.

• Support global Quality and Regulatory IT initiatives and digital transformation projects.

• Provide training and support to end-users.

• Assist with project management and ensure the timely delivery of IT solutions.

⛳️ Requirements

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

• Over 3 years of experience in IT business analysis, system ownership, or validation within the Life Sciences/Pharmaceutical/Medical Device sector.

• Practical experience with Veeva, TrackWise, or other Regulatory/Quality applications.

• In-depth knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance.

• Capability to develop and execute test scripts, validation documents, and system records.

• Technical expertise in SQL, system integrations, and application configuration.

• Proficiency in both spoken and written Spanish and English is essential.

• Basic understanding of Java, .NET, and SQL.

• Familiarity with AWS or Azure, including cloud application deployment, configuration, and maintenance.

• Experience with CSV, GxP requirements, and the drafting and execution of IQ/OQ/PQ scripts.

• Knowledge of SaaS environments, Veeva Vault Platform, Salesforce-based systems, workflows, lifecycles, and user permissions.

• Hands-on experience with Veeva Vault QMS or TrackWise Digital.

• Understanding of regulatory processes and submissions.

• Strong analytical, problem-solving, communication, collaboration, and attention-to-detail skills.

• Preferred: Experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments.

• Preferred: Basic project management experience utilizing Agile, Waterfall, or hybrid methodologies.

🏝️ Benefits

• Reasonable accommodations available for individuals with disabilities worldwide.

• Opportunity for remote work.

• End-user training and support provided.