About this role
Job title: Senior IT Change Management Specialist
About the Role 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) in a regulated GxP environment. This senior individual contributor provides structure, governance, and visibility across changes impacting systems, infrastructure, and processes to enable compliant, efficient technology implementations while minimizing risk.
What You'll Do
- Plan, coordinate, and oversee ongoing and new IT changes across systems, infrastructure, and processes; maintain the IT change calendar and roadmap; ensure proper documentation and lifecycle management.
- 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 executive-level updates.
- Support ITIL-based Change Management practices; ensure proper approvals, risk assessments, and documentation standards; support Change Advisory Board (CAB) meetings and governance processes.
- Collect, analyze, and interpret data related to IT changes, validation, and quality activities; develop and maintain dynamic reports and dashboards; provide insights to inform implementation decisions.
- Assess change impacts, risks, and dependencies across IT and GxP systems; support evaluation of software/hardware changes, upgrades, migrations, and process improvements; ensure alignment with compliance requirements.
- Collaborate with IT Quality & Compliance teams to align changes with CSV/CSA validation requirements; ensure audit readiness and an appropriate validation posture.
- Plan, schedule, and facilitate recurring and ad hoc meetings (e.g., CAB, stakeholder reviews); document outcomes, action items, and follow-ups.
- Support demand planning and resource forecasting; help leadership prioritize change initiatives based on business needs and capacity.
- Identify opportunities to improve change management processes and workflows; leverage tools, automation, and AI capabilities to enhance efficiency and reporting.
What We're Looking For
- Bachelor’s degree in IT, Business, Quality, or related field (or equivalent experience).
- Minimum 8 years of experience in IT project management, coordination, or change management.
- Strong understanding of ITIL Change Management, IT systems/infrastructure, and GxP/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.
Nice to Have
- 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.
Compensation & Benefits
- Salary range: $153,000 - $178,000 (SF Bay Area); comprehensive benefits and an equity component.
- This role is located in San Carlos, CA with hybrid work arrangements (minimum 2-3 days onsite per week).