IT/OT Infrastructure Quality Manager

Job Description Summary

The IT/OT Infrastructure Quality Manager is responsible for ensuring end-to-end quality, compliance, and governance of Infrastructure assets throughout their lifecycle within Global IT. Serving as the primary Quality partner for the Infrastructure domain, this role provides oversight across hosting, network services, cloud platforms, end-user computing, and related IT infrastructure services.

The incumbent ensures Infrastructure assets and services are compliant, controlled, audit-ready, and aligned with GxP, Data Integrity, Computer Software Assurance (CSA), and Global Quality requirements. The role also provides quality oversight for Infrastructure-related projects, supporting validation activities, risk management, and continuous improvement initiatives.

Key Responsibilities

Infrastructure Quality & Compliance

• Provide end-to-end quality oversight of Infrastructure assets across their lifecycle, including operation, change management, periodic review, and retirement.
• Act as the primary Quality partner to Infrastructure leadership, service owners, and technical teams.
• Ensure Infrastructure assets and services remain compliant, controlled, and inspection-ready in accordance with GxP, Data Integrity, and Global Quality requirements.
• Define, maintain, and apply Infrastructure-specific quality and validation approaches aligned with IT Quality standards, CSA methodologies, and risk-based principles.

Lifecycle Governance & Oversight

• Oversee lifecycle quality processes, including change controls, deviations, CAPAs, risk assessments, and periodic reviews.
• Monitor Infrastructure quality performance, compliance metrics, and risk trends, driving continuous improvement and preventive actions.
• Ensure effective governance and quality controls are embedded within Infrastructure operations and service management processes.

Project Quality Management

• Provide independent quality oversight for Infrastructure-related IT projects, including participation in project tollgates, review and approval of key deliverables, and oversight of project risks and issues.
• Serve as Project Quality Manager and/or Validation Coordinator for selected Infrastructure initiatives, ensuring compliance with applicable quality and validation requirements.
• Accept ownership of Infrastructure assets during project handover, ensuring validation documentation is complete and operational readiness requirements are met.

Audit & Inspection Readiness

• Support internal audits, supplier audits, regulatory inspections, and quality assessments related to Infrastructure assets and services.
• Coordinate audit preparation activities, facilitate responses to observations, and ensure timely closure of corrective and preventive actions.
• Maintain a state of inspection readiness across the infrastructure domain through proactive compliance management and continuous monitoring.

Required Qualifications

• Bachelor's degree in information technology, Computer Science, Engineering, Life Sciences, or a related discipline.
• Significant experience in IT Quality, Computer System Validation (CSV), Computer Software Assurance (CSA), or Quality Assurance within regulated environments.
• Strong understanding of Infrastructure technologies, including cloud platforms, hosting, networks, end-user computing, and IT operations.
• Experience working within GxP-regulated environments and knowledge of Data Integrity requirements.
• Proven experience managing quality activities related to IT projects, validation, risk management, and compliance processes.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, healthcare, or other highly regulated industries.
• Knowledge of ITIL, COBIT, ISO 27001, and Infrastructure governance frameworks.
• Certification in Quality, Validation, Project Management, or IT Service Management methodologies.
• Strong stakeholder management, communication, and influencing skills.