Job Description

As the Consultant, IT EHS/QA Apps, you will: Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements. Serve as the functional business analyst, gathering and analyzing business 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 in collaboration with IT and business teams. Act as the primary liaison between IT, business process owners, and external vendors. Key Responsibilities 1. Technical Leadership System Support Lead the technical configuration, maintenance, and optimization of EHS and Quality systems like TrackWise (QMS), LabVantage LIMS, and Benchmark SaaS Provide technical expertise in AWS-based cloud solutions, SaaS platforms, and on-prem EHSS application architectures. Support the implementation of EHSS dashboards, analytics, and reporting tools to provide real-time compliance insights. Analyze, troubleshoot, and resolve technical issues, ensuring high availability and performance of applications. Work closely with business stakeholders, vendors, and IT teams to align solutions with business needs. 2. Application Development Integration Manage and support EHS and Quality applications used for compliance tracking, incident management, occupational health, and environmental sustainability reporting Support and oversee application enhancements, upgrades, and deployments in compliance with IT governance policies. Collaborate with developers, system architects, and business analysts to design and implement solutions that integrate with other enterprise systems (ERP, HRIS, and BI tools). Ensure seamless data flow between systems through API integrations, middleware, and ETL processes. 3. 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. 2. 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 Vantive s digital transformation strategy. 3. System Administration Continuous Improvement Proactively monitor, maintain, and optimize application performance, security, and compliance. Identify and recommend improvements, automation opportunities, and best practices to enhance system efficiency. Train and mentor junior IT team members and provide technical leadership in the EHSS Quality IT space. 4. 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. 5. Stakeholder Collaboration Project Support Act as a key liaison between IT and EHSS and Quality business stakeholders. Support global Quality and EHSS 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. 6. 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. Validation Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts Cloud Computing and Data Management: Familiarity with SaaS environments (e.g., Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions. Regulatory Domain: Hands-on experience with platforms like TrackWise Digital, LabVantage LIMS. Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc. egulatory authorities, global registration of products, 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. 7. Soft Skills Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks. Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance. Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders. Ability to translate technical concepts into actionable insights for non-technical teams (e.g., explaining validation requirements to QA). Project Management: Basic project management skills to coordinate system upgrades (e.g., Veeva s 3 annual releases), implementations, or process improvements. Familiarity with methodologies like Agile or Waterfall, often used in IT projects. Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits. Qualifications Experience Must-Have Qualifications 8+ years of experience in IT application support, preferably in regulated healthcare, pharma, life sciences, or EHSS industries. Hands-on experience with applications such as Benchmark Gensuite, TrackWise (QMS) and LabVantage LIMS.or other EHSS/Quality applications. Strong knowledge of AWS (including cloud security, deployment, and infrastructure management). Experience with SaaS platforms, system integration, APIs (REST/SOAP), and middleware solutions. Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance. Ability to troubleshoot complex technical issues, perform root cause analysis, and provide long-term solutions. Excellent analytical, communication, and problem-solving skills. Certifications in AWS, EHSS/Quality systems, or ITIL are a plus. Bachelor s or Master s degree in Computer Science, Information Systems, or a related field. Preferred Qualifications Experience with SQL, .NET, Java, or scripting languages for system troubleshooting and automation. Familiarity with ITSM tools (e.g., ServiceNow) and Agile methodologies. Knowledge of business intelligence and reporting tools (e.g., Tableau, Power BI) for Quality and EHSS applications. Experience with Veeva, 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.