Senior IT Specialist, Regulatory Systems – Veeva RIM

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

💻 IT Support

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Vantive

WebsiteLinkedInAll Job Openings

10,000+ employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams globally. For 70 years, Vantive has driven meaningful innovations in kidney care. The company’s solutions and services deliver over 1 million touchpoints each day to patients around the world. Vantive focuses on elevating the dialysis experience through digital solutions and advanced services, while also investing in transforming vital organ therapies beyond kidney care. The company aims to provide therapies that fit more easily into providers’ practices and patients’ lives, offering greater flexibility and efficiency for care teams, and longer, fuller lives for patients.

📋 Description

• Own and manage Quality and Regulatory IT applications • Serve as functional business analyst by gathering and analyzing business needs and defining requirements • Architect and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications • Lead system validation, testing execution, and change management in a regulated environment • Maintain compliance with GxP, 21 CFR Part 11, CSV, FDA, ISO 13485, and global regulatory standards • Maintain functional requirements, design specifications, validation plans, and change control records • Ensure systems remain in a validated state throughout their lifecycle • Develop and execute test scripts, UAT scenarios, and validation plans • Manage risk assessments, audits, and regulatory inspections related to validation and compliance • Oversee system upgrades, patches, maintenance, defect triage, root cause analysis, and issue resolution • Liaise between IT, Quality, Regulatory, business process owners, and external vendors • Support global Quality and Regulatory IT projects and digital transformation initiatives • Provide end-user training and support • Assist with project management and coordinate timely delivery of IT solutions

🎯 Requirements

• 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 • Basic understanding of Java, .NET, and SQL • Knowledge of AWS or Azure and cloud application deployment, configuration, and maintenance • Experience with CSV, GxP requirements, and writing and executing IQ/OQ/PQ scripts • Familiarity with 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 • 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 with Agile, Waterfall, or hybrid methodologies

🏖️ Benefits

• Reasonable accommodations for individuals with disabilities globally • Remote position • End-user training and support

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume