Senior IT Specialist, Regulatory Systems – Veeva RIM

🔥 10 minutes ago

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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 Regulatory applications according to business requirements • Serve as functional business analyst by gathering and analyzing needs, defining requirements, and architecting solutions • Lead system validation, testing execution, and change management in a regulated environment • Oversee system maintenance, upgrades, defect tracking, and issue resolution • Act as liaison between IT, business process owners, and external vendors • Ensure 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 • Translate business needs into functional and technical specifications • Develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications • Develop and execute test scripts, UAT scenarios, and validation plans • Manage risk assessments, audits, and regulatory inspections related to system validation • Oversee upgrades, patches, maintenance, issue triage, root-cause analysis, and defect resolution • Support global Quality and Regulatory IT projects and digital transformation initiatives • Provide end-user training and support • Assist with project management and coordinate system upgrades, implementations, and process improvements

🎯 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, or 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 • 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 such as Veeva Vault Platform and Salesforce-based systems • Hands-on experience with Veeva Vault QMS or TrackWise Digital • Understanding of regulatory processes and submissions, including registration and publishing • Spanish and English speaking and written communication skills are mandatory • Ability to analyze complex business requirements and map them to system capabilities • Problem-solving skills for troubleshooting system issues while maintaining compliance • Strong verbal and written communication skills for IT, QA, regulatory affairs, and business stakeholders • Attention to detail in documenting system changes, validation protocols, and SOPs • Preferred: experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments • Preferred: basic project management experience with Agile, Waterfall, or hybrid methodologies

🏖️ Benefits

• Remote position • Reasonable accommodations for individuals with disabilities • Opportunities for growth and learning to advance your career