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The Senior IT Change Management Specialist is responsible for planning, managing, and communicating IT Change Management activities across IT and IT QSC (Quality, Security, Compliance). This role operates as a senior individual contributor and program coordinator, providing structure, governance, and visibility across all IT changes impacting systems, infrastructure, and processes in a regulated GxP environment. This position plays a critical role in enabling the business to implement technology changes efficiently while maintaining compliance, minimizing risk, and ensuring alignment with organizational priorities. The role partners closely with IT leadership but does not have direct people management responsibility.

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.

• Bachelor's degree in IT, Business, Quality, or related field
• Minimum 8 years of experience in IT project management, coordination, or change management roles. Other combinations of education and/or experience may be considered.
• Strong understanding of:
  • ITIL Change Management best practices
  • IT systems, infrastructure, and operations
  • GxP environments and regulatory requirements (21 CFR Part 11)
• Experience with:
  • Change management processes and governance
  • Data collection, analysis, and reporting
  • Cross-functional stakeholder coordination
• Ability to plan and facilitate meetings across diverse stakeholder groups.
• Strong analytical and problem-solving skills.

• Experience with CSV/CSA (Computer System Validation / Computer Software Assurance).
• Understanding of IT Quality & Compliance activities (audits, validation, CAPAs).
• Experience with AI tools for data analysis, reporting, or process optimization.
• Familiarity with tools such as Smartsheet, Excel, Word, FreshService.
• Experience in life sciences or regulated environments.