Change Planning & Coordination
• Plan, coordinate, and oversee ongoing and new IT changes across systems, infrastructure, and processes.
• Maintain and manage the IT change calendar and roadmap.
• Ensure proper documentation, tracking, and lifecycle management of all changes.
Stakeholder Engagement & Communication
• Collaborate with IT, Quality Assurance, Security, and business stakeholders to gather and communicate change requirements.
• Translate technical changes into clear, business-friendly communications.
• Provide regular updates to stakeholders, including executive-level summaries.
Change Governance & IT Infrastructure Library (ITIL) Alignment
• Support and enforce ITIL-based Change Management best practices.
• Ensure changes follow appropriate approval workflows, risk assessments, and documentation standards.
• Support Change Advisory Board (CAB) meetings and governance processes.
Data Analysis & Reporting
• Collect, analyze, and interpret data related to IT changes, validation, and quality activities.
• Develop and maintain dynamic reports and dashboards for stakeholders.
• Provide insights to support decision-making on implementations, upgrades, migrations, and deprecations.
Change Impact & Risk Management
• Assess and communicate change impacts, risks, and dependencies across IT and GxP systems.
• Support evaluation of changes related to software/hardware implementations, upgrades, migrations, and process improvements.
• Ensure alignment with compliance requirements including 21 CFR Part 11 and GxP standards.
Validation & Compliance Support
• Collaborate with IT Quality & Compliance teams to align changes with CSV/CSA validation requirements.
• Support documentation and processes required for validated systems.
• Ensure change activities maintain audit readiness and compliance posture.
Meeting Facilitation & Coordination
• Plan, schedule, and facilitate recurring and ad hoc meetings (e.g., CAB, stakeholder reviews).
• Document meeting outcomes, action items, and follow-ups.
Demand Planning & Resource Forecasting
• Support planning and forecasting of change demand vs. available resources.
• Assist leadership in prioritizing change initiatives based on business needs and capacity.
Continuous Improvement & Process Optimization
• Identify opportunities to improve change management processes and workflows.
• Leverage tools, automation, and AI capabilities to enhance efficiency and reporting.