Senior Operational Lead – IT Operations & GxP Systems; Freelance

Senior Operational Lead – IT Operations & GxP Systems (Freelance) Context

We are supporting a complex enterprise system landscape operating in a regulated environment
, including validated (GxP) and non-validated systems with different criticality levels.

We are looking for a senior freelance Operational Lead to ensure stable, compliant, and efficient operational readiness and ongoing operations of these systems across their full lifecycle.

This is a hands-on operational leadership role
, with strong ownership over compliance, IT Service Management, and service stability
.

The Operational Lead is accountable for ensuring that enterprise systems are operated in accordance with:

• applicable GxP regulations
• internal quality and compliance standards
• IT Service Management (ITSM) best practices

The role works in close collaboration with validation, testing, product, technical, quality, and business stakeholders to ensure controlled changes, operational stability, configuration integrity, and agreed service levels.

The operational scope includes:

• at least one validated GxP system
• additional non-validated or supporting systems

Operational responsibilities apply accordingly, taking into account the different regulatory and validation statuses of the systems involved.

• Ensure system operations comply with applicable GxP regulations
  , internal quality frameworks, and policies
• Maintain operational readiness of validated systems post-validation
• Support audits and inspections
  , providing operational documentation, evidence, and explanations
• Collaborate closely with Validation and Quality stakeholders to ensure alignment between validation deliverables and operational processes

The Operational Lead is accountable for implementing and maintaining ITSM practices in line with enterprise standards, including:

• Own and coordinate Incident Management for validated and critical systems
• Ensure timely detection, logging, classification, prioritization, and resolution of incidents using Service Now (or equivalent ITSM tools)
• Lead Major Incident Management
  , including escalation, stakeholder communication, and coordination of resolution activities
• Ensure proper assessment of GxP, quality, and validation impact of incidents
• Ensure regulatory-compliant incident documentation, traceability, and formal closure
• Monitor incident trends and drive corrective actions

Ensure all changes (application, infrastructure, configuration) are:

• planned
• risk-assessed
• approved
• tested
• deployed in a controlled and compliant manner

Coordinate releases in alignment with validation and quality requirements

Ensure proper documentation, traceability, and impact assessment of changes

Act as a key operational stakeholder in Change Advisory Board (CAB) processes

• Ensure accurate and up-to-date service configuration and system documentation
• Maintain integrity of the validated configuration baseline
• Ensure configuration changes are aligned with validation status and documented accordingly
• Define, agree, and monitor Service Level Agreements (SLAs) and Operational Level Agreements (OLAs)
• Monitor service performance and availability
• Drive continuous improvement of service quality and operational efficiency
• Lead and coordinate Problem Management activities
• Identify root causes of recurring incidents
• Ensure Corrective and Preventive Actions (CAPAs) are defined, implemented, and tracked
• Drive long-term service stability and risk reduction

Act as the primary operational point of contact for the systems in scope

Coordinate across:

• IT and infrastructure teams
• validation and quality functions
• vendors and external service providers
• business stakeholders

Ensure clear and controlled handover from project/validation to steady-state operations

Support escalations and decision-making when required

• Technical Product Owner
• Product / Solution Owners
• IT Operations & Infrastructure teams
• Application Support teams
• Vendors and external service providers
• Business and operational stakeholders