IT Compliance Coordinator – Manufacturing & Operational Technology

Job Summary

We are seeking an experienced IT Compliance Coordinator to support compliance and governance activities for Manufacturing IT and Operational Technology (OT) systems in a GMP-regulated environment. The role will focus on maintaining inspection readiness, coordinating periodic reviews, managing system inventory updates, tracking compliance actions, and supporting SDLC and change control activities. The ideal candidate should have a strong understanding of GMP compliance, IT systems, and validation processes, along with experience coordinating activities across Quality, IT, Automation, Engineering, and Manufacturing teams.

Key Responsibilities

• Coordinate and maintain periodic review schedules for GMP-regulated IT/OT systems, ensuring reviews are completed, documented, and approved on time.
• Track overdue periodic reviews, annual user access reviews, data restoration testing, and other compliance activities through closure.
• Create, update, and manage ServiceNow tickets for system inventory changes, equipment records, system attributes, and user access requests.
• Support ongoing compliance gap assessments by working with SMEs, reviewing applicable SOPs and work instructions, and tracking required corrective actions.
• Coordinate inspection readiness activities, including preparation of system storyboards, GEMBA walks, readiness meetings, and supporting documentation.
• Support supplier assessments by collecting required information, preparing supplier management documentation, and coordinating approvals.
• Provide coordination and compliance support for SDLC activities, including validation documentation, change control, and process adherence.
• Work closely with IT, OT, Quality, Automation, and Manufacturing teams to address compliance gaps and maintain system readiness.
• Manage compliance meetings, document minutes, assign action items, and follow up with stakeholders to ensure timely closure.
• Maintain compliance trackers, system inventories, status reports, and action logs using JIRA, Microsoft Teams, ServiceNow, and other applicable tools.
• Identify and escalate compliance risks, overdue actions, documentation gaps, and potential inspection readiness concerns.

Required Qualifications

• Bachelor's degree in Engineering, Information Technology, Life Sciences, or a related discipline.
• Experience supporting IT compliance, CSV, IT Quality, or validation coordination activities within a pharmaceutical, biotechnology, or medical device environment.
• Good understanding of GMP, GxP, SDLC, change control, and computer system validation (CSV) principles.
• Hands-on experience with ServiceNow for managing IT service requests, system records, or change-related tickets.
• Experience using JIRA, Microsoft Teams, or similar tools for action tracking and project coordination.
• Familiarity with periodic reviews, access reviews, system inventory management, and inspection readiness activities.
• Ability to work with cross-functional teams, coordinate meetings, maintain schedules, and follow up on outstanding activities.
• Strong documentation, reporting, organizational, and communication skills.

Preferred Qualifications

• Experience supporting Manufacturing IT, OT, automation, or GMP computerized systems.
• Knowledge of 21 CFR Part 11, GAMP 5, data integrity, and regulated system lifecycle requirements.
• Exposure to supplier qualification, compliance gap assessments, audits, or regulatory inspections.
• Experience working with Quality, IT Infrastructure, Automation, Engineering, and Manufacturing stakeholders.