Senior Specialist - Qualification Owner

Role Overview Merck Healthcare is looking for an experienced Senior Specialist - Qualification Owner to lead the design and implementation of document management infrastructure solutions. This role is central to ensuring that all document management systems align with the company's digital strategy and meet stringent regulatory compliance standards including GDP and GxP. The ideal candidate will bring strong technical leadership, problem-solving capabilities, and a collaborative mindset to drive infrastructure excellence across on-premises and cloud environments. Key Responsibilities - Lead the design and deployment of document management infrastructure solutions in line with the company's digital roadmap - Provide expert consultation on infrastructure setup for both on-premises and cloud-based document management platforms - Ensure all infrastructure configurations comply with GDP, GxP, and other applicable regulatory standards - Assess, evaluate, and recommend suitable hosting models and infrastructure solutions for document management applications - Develop and maintain thorough technical documentation covering all infrastructure configurations - Collaborate with IT, Quality, Regulatory, and business stakeholders to ensure document management systems meet organisational requirements - Guide and mentor teams on infrastructure decisions while clearly communicating technical concepts to non-technical stakeholders - Manage infrastructure projects end-to-end with minimal disruption and lead change management initiatives effectively Required Qualifications - Bachelor's degree in Computer Science, Information Technology, or a related technical discipline - Minimum of 10 years of hands-on experience in IT infrastructure management - Prior experience in IT, pharmaceutical, life sciences, or other regulated industries preferred - Proficiency in on-premises infrastructure, cloud deployment across AWS, Azure, or GCP, hybrid cloud architecture, and Infrastructure as Code principles - Hands-on experience implementing and supporting enterprise-level document management solutions - Working knowledge of virtualisation technologies and containerisation tools such as VMware, Docker, and Kubernetes - Sound understanding of infrastructure security best practices, network architecture, and compliance requirements - Familiarity with GxP and GDP principles and regulatory expectations for document management systems - Experience with computer system validation in regulated environments - Ability to identify and mitigate infrastructure-related risks in compliance with regulatory guidelines - ITIL certification and pharmaceutical regulatory compliance certifications are preferred Why Join Us Merck Healthcare fosters a culture of curiosity, inclusion, and innovation where every team member is empowered to make a meaningful impact on science, technology, and human progress. Join a globally diverse team that champions growth, collaboration, and the relentless pursuit of better solutions for patients and society.

- Minimum 10 years of IT infrastructure management experience - Expertise in cloud platforms including AWS, Azure, and GCP - Experience with hybrid cloud and Infrastructure as Code principles - Knowledge of virtualisation and containerisation using VMware, Docker, and Kubernetes - Understanding of GxP, GDP, and pharmaceutical regulatory compliance - Experience with enterprise document management systems - Computer system validation experience in regulated environments - Infrastructure security and network architecture knowledge - Risk assessment and mitigation capabilities - ITIL certification preferred - Bachelor's degree in Computer Science, IT, or related field

- Opportunity to work with a globally recognised healthcare and life sciences leader - Inclusive and diverse work culture - Career development and growth opportunities - Exposure to cutting-edge technology and innovation - Collaborative environment with cross-functional teams