- 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
