System Ownership & Governance
Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (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
Functional Business Analysis & Solution Design
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 Vantives digital transformation strategy
Validation, Testing & Compliance
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
System Maintenance, Enhancements & Issue Resolution
Oversee system upgrades, patches, and maintenance, recommending enhancements as needed
Manage issue triage, root cause analysis, and resolution for system defects
Work closely with business process owners to ensure applications align with operational needs
Coordinate with vendors and internal teams for system support and enhancements
Stakeholder Collaboration & Project Support
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

Technical Skills & Experience

The Ideal Candidate Should Have a Strong Technical Foundation With Hands-on Experience In Enterprise Application Support, Configuration, And Deployment
Key Technical Competencies Include
Programming & Scripting: Basic understanding of Java,
NET, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries
Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment
Application Deployment & Support: Familiarity with CI/CD pipelines, system integrations, web services (SOAP/REST APIs), and troubleshooting production issues
Validation & Compliance: Experience working in a regulated healthcare, pharma, or life sciences environment with understanding of CSV (Computer System Validation) and GxP requirements
The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications

Qualifications & Experience

Must-Have Qualifications

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, LabVantage LIMS, or other Quality/Regulatory 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
Bachelors degree in Computer Science, Information Systems, or a related field

Preferred Qualifications

Experience with Salesforce, AWS, Azure, or cloud-based environments
Basic project management experience (Agile, Waterfall, or hybrid methodologies)
Strong problem-solving and analytical skills to address complex system issues
Excellent communication and stakeholder management skills
Reasonable Accommodation

Sr Spec, IT QA RA Global Apps

Sr Spec, IT QA RA Global Apps