Global Pharmaceutical Change Manager

Over sixteen years leading enterprise-wide technologyenabled change in global pharmaceutical and biotech organizations, including SAP, Veeva, and AI-enabled programs, ensuring alignment with GxP, R&D, and IT guidelines

Certified in PROSCI change management, with a proven ability to design and execute global change strategies, readiness assessments, governance frameworks, training rollouts, and stakeholder engagement in matrixed organizations

Hands-on experience with AI and machine learning initiatives in pharma, combined with deep understanding of digital platforms (SAP, Veeva, LIMs, ELNs, cloud-based analytics) to drive adoption and optimize processes

Demonstrated ability to work effectively with global, crossfunctional teams, translating business and technology requirements into actionable change plans, while ensuring high adoption rates (95–99%) and aligning with organizational objectives

Leading a Change Management workstream in a large-scale technology program environment in a Veeva and SAP transformation program

Creation of a global Change Management plan, including a change agent network to training rollouts

Compilation of the Change Management Governance Framework

Led an enterprise-wide Change Workstream for a technology transformation with AI components, including Veeva & SAP implementations

Leading change agent training and training/adoption rollout, ensuring a 99% user adoption rate

Partnered successfully and effectively with technology and business process-led program teams

Leading the global change management rollout of a new Pathology LIMS (PathHub) post M&A of Backlog's Pathology by HCA

Creation of a change management plan including ensuring user adoption was 95%+

Leading the definition of the change management workstream and working with a technology team, identifying technological and process improvements for a global programme focusing on redefining clinical data flow

Authored the Change Impact Analysis, SOP Impact Assessment & Plan (impact assessment, creation/revision/retirement of SOPs, approval in line with AZ governance)

Led Change Readiness Assessment authoring

Led the change workstream for a global change and transformation programme implementing Dotmatics’ solution offerings (LIMs/ELNs etc.)

Compiled (and partially executed) the Change Impact Assessment and Change Readiness plans as well as the training, adoption rollout plan

Directed global transformation program aligning processes and SOPs across Medical Affairs, Regulatory, Pharmacovigilance, Clinical Development (incl. Supply Chain) and R&D Quality

Mapped all to updated document regulatory management system (Veeva Easidoc QMS) to ensure inspection readiness

Compiled a Project Management Framework sponsored by the global head of Quality

Artificial Intelligence programme implementations for two large pharma clients

Constructed the Change Management Plan for both Roche and Bayer for the PVAI rollout

Defining a change management blueprint for technological change within the R&D department

Conducted risk assessment and management of key R&D risks (specifically GxP) at programme and enterprise level

Undertook Change Management planning and authored SOP, WI and GUI updates for Clinical Operations, Pharmacovigilance Manufacturing (CMC) Regulatory and Medical Affairs

Led and managed the delivery of a business-critical PharmacoVigilance outsourcing programme in a multi-vendor setting with accountability to VP of Med Affairs

Developed and deployed an IDMP alignment plan (MedPID & PhPID) for the PV outsourcing in line with E2B R3

Defined and created an interface for Trackwise (ERP) clinical supply chain to PV software and provided formal & informal coaching

Defined and created a 3-year global roadmap including change management for the Global Work Stream

Applied a hybrid agile/waterfall approach

Delivered a cloud-based Clinical Analytics and Reporting service for Clinical Operations

Coordinated between Business (Clinical Operations) and IT

Led and authored global rollout of a cloud-based SAS 9.4 upgrade program

Defined strategy and business case

Selected and managed outsourced IT vendors