Job Description

Job Summary: Vantive is seeking a Technical Functional professional with expertise in Regulatory Compliance Systems and other RD application implementations to support digital transformation initiatives. The ideal candidate will be the single point of contact (SPOC) of designated information technology systems, including but not limited to hardware, software, databases, applications. This role requires a strong blend of technical expertise, hands-on implementation experience, and business process understanding to configure, integrate, and optimize these systems within a regulated environment. Key Responsibilities: System Implementation: Lead end-to-end implementation of cloning Compliance Builder, Regulatory Asset Manager and other apps in RD by collaborating with SI partners and vendors Develop and support Integrations/APIs, middleware solutions, and automation workflows. Perform system configuration, customization, and validations. Develop and implement standard operating procedures (SOPs), templates, and user access controls for compliance and efficiency. Conduct user training sessions, workshops, and documentation development to drive system adoption. System Incident Management: Monitor system performance metrics, identify areas of improvement, implement optimization strategies to enhance efficiency and reliability. Identify and mitigate risks associated with system operations, data integrity, and/or cyber security threats. Alert and escalate technical issues, concerns to functional leads, architects, and/or program leads. Communicate with incident commanders and service desk in accordance with SLA s. Implement disaster recovery plans, backups, and system monitoring. Continuous Improvement: Collaborate with BRM/MRM, EA, business owners, other IT functions, and/or with 3rd party system owners on system enhancements and capabilities to translate business requirements into technical designs that are globally scalable aligning with organization road maps, goals, and initiatives. Implement system upgrades and enhancements to improve systems performance, functionality, and/or security. Ensure the system is secure and up to date (patching, version, certificates etc.,) and the system is compliant with authentication policies. Compliance Validation Support Ensure applications deployments meet GxP and FDA 21 CFR Part 11 standards. Assist in computer system validation (CSV) activities, including IQ/OQ/PQ documentation and audit readiness. Develop and maintain system risk assessments, validation scripts, and traceability matrices. Qualifications Experience: Required: Bachelor s degree in computer science, Computer Engineering, or other related fields. 8 + years of experience in Information Systems, experience in multiple areas of IT. Experience with Compliance Builder, Regulatory Asset Manager, or similar compliance-focused applications. Strong knowledge of infrastructure management on cloud service providers (CSP - AWS Preferred), cloud computing, and IT operations. Experience with programming languages (e.g., C#, .NET, Java, Python), web technologies (e.g., ASP.NET Core, Angular, REST API s), and database technologies. Familiarity with software development tools and methodologies, including version controls systems, and testing frameworks. Experience with administration and maintenance of CI/CD and DevOps tools, including managing user accounts, performing system upgrades, handling license and certificate renewals, and ensuring high availability and security compliance across environments. Understanding of regulatory and compliance processes in industries such as medical devices, life sciences, healthcare, or manufacturing. Additional Skills: 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. Recruitment Fraud Notice