12 дней назад
Senior IT Specialist, Regulatory Systems (Veeva RIM) | Remote (Veeva RIM)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior IT Specialist, Regulatory Systems (Veeva RIM) | Remote (Veeva RIM): Owning and improving Quality and Regulatory applications, including Veeva, TrackWise, and LabVantage LIMS, with an accent on functional analysis, system configuration, validation, and regulatory compliance. Focus on designing compliant solutions, executing CSV and UAT testing, maintaining validated system states, and resolving complex application issues in a life sciences environment.
Location: Remote across Mexico; the posting lists Guadalajara, Jalisco and is open to applicants across the country.
Company
develops vital organ therapy solutions and digital services, with a focus on kidney care, dialysis, and broader life sciences applications.
What you will do
- Own and govern Quality and Regulatory IT applications, keeping them compliant with GxP, 21 CFR Part 11, CSV, FDA, ISO 13485, and global regulatory standards.
- Gather business requirements, map workflows, define functional and technical specifications, and design configurable solutions.
- Support and optimize Veeva, TrackWise, LabVantage LIMS, Salesforce-based, and other Quality and Regulatory applications.
- Lead validation activities, including risk assessments, validation plans, test scripts, UAT scenarios, audits, and inspection support.
- Coordinate upgrades, patches, maintenance, defect triage, root cause analysis, issue resolution, and vendor collaboration.
- Act as a liaison across IT, Quality, Regulatory, business stakeholders, developers, and cloud teams while supporting projects, training users, and system adoption.
Requirements
- Bachelor’s degree in Computer Science, Information Systems, or a related field.
- At least 3 years of experience in IT business analysis, system ownership, or validation within life sciences, pharmaceutical, or medical device environments.
- Hands-on experience with Veeva, TrackWise, or other Regulatory and Quality applications.
- Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation, validation documentation, and IQ/OQ/PQ scripts.
- Technical knowledge of SQL, system integrations, application configuration, and basic Java and .NET troubleshooting; familiarity with AWS or Azure.
- Spanish and English communication skills are mandatory.
Nice to have
- Experience with Veeva Vault, Salesforce, AWS, Azure, or other cloud-based environments.
- Basic project management experience with Agile, Waterfall, or hybrid methodologies.
- Experience coordinating implementations, upgrades, or process improvements.
Culture & Benefits
- Remote work available across Mexico.
- Work focused on improving patient and care-team outcomes through vital organ therapy solutions.
- Collaboration with global IT, Quality, Regulatory, business, and vendor stakeholders.
- Reasonable accommodations are available for candidates with disabilities during the application and interview process.
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