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

Köln, Germany

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.

Role Overview

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.

System Scope (Generalized)

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.

Key Responsibilities

GxP & Regulatory Compliance

  • 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

IT Service Management (ITSM)

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

Incident Management

  • Own and coordinate Incident Management for validated and critical systems

  • Ensure timely detection, logging, classification, prioritization, and resolution of incidents using ServiceNow (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

Change & Release Management

  • 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

Service Configuration Management

  • 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

Service Level Management

  • 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

Problem Management

  • 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

Operational Governance & Stakeholder Management

  • 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

Key Interfaces (Typical)

  • Validation Lead

  • Test Lead

  • Technical Product Owner

  • Product / Solution Owners

  • IT Operations & Infrastructure teams

  • Application Support teams

  • Vendors and external service providers

  • Business and operational stakeholders

Required Experience & Competencies

Must-have

  • Strong experience in GxP-regulated environments (pharma, biotech, medical devices, or similar)

  • Solid understanding of validated IT systems and lifecycle management

  • Proven experience with IT Service Management frameworks (e.g. ITIL)

  • Hands-on experience with ServiceNow (or equivalent), including:

    • Incident Management

    • Change & Release Management

    • Problem Management

    • Configuration Management (CMDB)

    • Service Level Management

  • Ability to operate confidently in complex, regulated, multi-stakeholder environments

  • Strong documentation, communication, and stakeholder management skills

Nice-to-have

  • Prior experience acting as Operational Lead or Service Owner for validated systems

  • Experience in audit-facing roles

Engagement Model

  • Type: Freelance / Contract

  • Allocation: Full-time (1 FTE)

  • Duration: Long-term potential

  • Start: Short notice possible

  • Work mode: Mostly remote with some few potential onsite visits

How to Get in Touch

Please reach out with:

  • A short CV or profile

  • Brief summary of relevant GxP / ITSM experience

  • Availability and engagement model

Contact: talents@m-tech1.com

Apply Now!

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