Manager Information Systems - docuBridge

Roles & Responsibilities :

• Collaborate with internal Regulatory Operations stakeholders and vendor partner (Lorenz) to ensure accurate interpretation of requirements, compliant submission delivery, and successful deployment of the solution
• Partner cross-functionally with Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and convert them into scalable, compliant solutions
• Define and manage project plans, resource allocation, timelines, and key deliverables across the entire lifecycle : assessment, procurement, configuration, validation, release, and support
• Lead validation efforts by overseeing creation of validation plans, IQ / OQ / PQ protocols, and other documentation in alignment with GxP, 21 CFR Part 11, and Annex 11
• Ensure submission readiness through structured document workflows, lifecycle management, and integration with systems like Regulatory Veeva Vault
• Oversee user access, role-based privileges, and audit trail configurations to uphold system security and compliance
• Own change control for the submission system aligned with ITIL, ensuring traceability for all changes, patches, and configurations
• Develop training materials and deliver user training sessions for onboarding and system adoption
• Monitor production performance, troubleshoot incidents with Lorenz, and resolve issues with minimal business impact
• Drive continuous improvement initiatives to optimize usability, performance, and compliance
• Track KPIs and provide leadership with regular updates on system performance, adoption, and throughput
• Contribute to roadmap planning, identifying integration opportunities with tools like Lorenz eValidator and regulatory intelligence platforms
• Serve as the SME for structured submissions during audits, inspections, and regulatory reviews
• Rapidly prototype solutions and translate concepts into functional code
• Adapt to agile methodology and lead cross-functional teams effectively
• Utilize Jira and ServiceNow for project tracking and service management
• Maintain technical documentation including design, deployment, operations, and disaster recovery
• Monitor system health, performance, and capacity using dashboards and tracking tools
• Implement and manage system security to guard against unauthorized access and vulnerabilities
• Respond to and resolve incidents, conduct root cause analysis, and implement preventive solutions

Basic Qualifications :

Must-Have Skills :

Good-to-Have Skills :

Professional Certifications :

Soft Skills :

Shift Information :

Skills Required

Regulatory Compliance, Gxp, ectd