Preparing Adaptimmune IT for first Pre-Approval Inspection through development/improvement of IT policies and procedures and bringing GxP systems up to compliance with new standards. Protecting our license to operate by assuring compliant delivery of new technology solutions and effective change management of existing systems.

Developed General IT Controls for SOx-regulated computer systems and a suite of IT Security Policies and Procedures (based on NIST and ISO 27001). Managed a global team of risk and compliance professionals.

Supported development of business proposals and provided copywriting for client presentations.

Drove effective risk management processes at all levels in the IT organization. Partnered with key business customers to identify critical business systems and assure they had the appropriate level of resilience (high availability, data backup, and disaster recovery).

Developed the internal audit methodology and annual global IT audit plan as a key component of a corporate initiative to improve risk management and assurance. Led effective implementation of "2nd Line" Assurance function for AZ IT.

Created an IT project assurance framework and managed a global team of IT auditors providing independent assurance that projects delivered intended benefits in compliance with AstraZeneca processes and procedures.

Appointed to Senior Quality role on the global consolidation of local functional IT teams and the outsourcing of application maintenance services for over 4000 systems. Led offshore quality systems audits of a number of top-tier offshore IT Service Providers.

Managed the computer validation and testing team supporting AZ’s North American Operations & Finance systems and led a project to transform the sourcing model from local to offshore. Implemented a risk-based approach to change management for AZ's North American ERP system in line with FDA guidance.

Led the North American implementation of a new CMMI and ISO 9001-based quality management system for R&D IT. Supported validation of new system development projects and changes to existing regulated R&D systems.

Managed validated computerized systems supporting GMP processes for Schering-Plough's Technical Operations. Led remediation of document management-related findings under FDA Consent Decree.

Provided network administration and desk-side support to the site while driving remediation of FDA observations related to computer systems in the Quality Control labs.