Senior Lead - QC System - Empower

Job Purpose:

The Senior Lead - QC System - Empower will deliver and support Empower (CDS) solutions for Quality Control (QC) laboratories. The role includes project work and BAU support, platform delivery, upgrades, automation, L2/L3 support, version upgrades and practical exposure to automation capabilities.

The role diagnoses complex issues using logs, metrics, interfaces, data flows and system behaviour and implements approved corrective actions.

Key Responsibilities:

• Configure and support Empower projects, methods, processing methods, reports and user security for QC labs.
• Translate QC and analytical requirements into Empower configurations following defined standards.
• Maintain Empower master data, templates and configuration items in line with global governance.
• Configuration and scripts held under version control, peer review before release, scripted or automated regression tests, and test evidence kept with the change.
• Contribute to the design and execution of Empower Citrix to Azure migration (environment build, cutover planning, testing and rollout).
• Support Empower version upgrades (assessment, remediation, regression testing, deployment).
• Work with infrastructure and platform teams to optimise performance, scalability and resilience in Azure.
• Participate in integration work (e.g. LIMS, instruments, archival solutions) as part of modernisation projects.
• Use Empower automation capabilities (e.g. custom calculations, processing workflows, scheduling, scripts/macros where applicable) to streamline QC operations.
• Identify opportunities to automate repetitive tasks and standardise analytical workflows.
• Document and share reusable automation patterns and best practices within the team.
• Uses approved AI assistants to build and test Empower configuration and scripts and checks the output before submitting it for review.
• Provide Level 2/3 support for incidents, problems and service requests related to Empower.
• Perform root cause analysis for complex issues and implement corrective and preventive actions.
• Deliver small enhancements and configuration changes through formal change management.
• Support periodic maintenance activities, including patching, housekeeping and performance tuning.
• Follow GxP, data integrity and quality procedures in all Empower changes and support activities.

Key Relationships / Customers:

• Business and Site Stakeholders
• Manufacturing, Quality, Laboratory, Supply Chain and MSAT stakeholders
• Site engineers, automation teams, super users and key users
• Business Process Owners and operational risk owners
• Digital & Technology Stakeholders
• Product Managers and Product Owners
• Solution and Enterprise Architects
• Engineering, DevOps, Data and Integration teams
• Service Managers, Cyber Security and Infrastructure teams
• Validation, Quality and technical assurance teams
• Technology vendors
• System integrators and specialist engineering partners
• Managed service and support providers

Basic qualifications:

• Bachelor's or master's degree in engineering, Computer Science, Life Sciences or a relevant technical discipline, or equivalent practical experience.
• 4+ years of hands-on experience with Empower CDS administration and configuration in QC / GMP environments.
• Experience supporting or implementing QC/analytical lab systems (preferably Empower) under GxP.
• Practical exposure to at least one of:
• Empower environment migrations (Citrix, virtualised or cloud-hosted setups).
• Empower version upgrades, including testing and validation.
• Empower automations (processing workflows, custom calculations, scripts, or scheduling tools).
• Good understanding of QC lab processes, chromatographic workflows and data integrity principles.
• Knowledge of CSV, 21 CFR Part 11, Annex 11 and data integrity (ALCOA+) in the context of CDS systems.
• Familiarity with ITIL-based service management and working with global support models.
• Exposure to scripting or automation tools used alongside Empower or other QC systems.

Preferred qualifications:

• Strong analytical and structured problem-solving skills.
• Ability to translate architecture and product direction into clear technical designs and implementation activities.
• Clear technical writing and disciplined maintenance of specifications, designs, test evidence and configuration records.
• Understanding of interfaces, workflows, data, environments, monitoring and operational support.
• Awareness of security, quality, validation, data integrity, resilience and change controls.
• Ability to collaborate across global business, site, engineering, architecture, product, service and supplier teams.
• Continuous-improvement mindset with emphasis on standardisation, reuse, automation and knowledge sharing.