Senior IT Change Management Specialist
Vaxcyte · San Carlos, CA · 2 wk ago
Information TechnologyFull-time
Essential Functions
- 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.
Requirements
- 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.
- Preferred:
- 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.
Benefits
We offer a competitive compensation package, comprehensive benefits, professional development opportunities, and a supportive work culture.