Consulting and support for business change and improvement. Focus on supporting clients through effective use of core skills: Quality Management, Project Management, Education & Learning.

Develop new business opportunities, manage client consulting relationships and assignments to deliver value, enable clients to become self-sufficient in dealing with change. Key areas of responsibility:
-Change Management,
-Quality Management System implementation, execution and continuous improvement,
-Project Management implementation and execution,
-Training event development and execution.

Led development, implementation and the required cultural changes for best practice Quality Management Processes for Computerised Systems, to ensure compliance with global regulatory authority requirements and corporate expectations. Quality direction and support to strategic business projects.

Led a team to implement a practical computerised system lifecycle management process, that met regulatory authority requirements and industry best practices. This enabled effective qualification and operation of production, lab and business systems, increasing readiness for successful regulatory authority inspections.

Raised site capability through development and delivery of a comprehensive regulatory topic training package. The package was rolled out across a manufacturing site, to 250+ employees, consultants, management and the executive team.

Provided a pragmatic quality assurance framework and support to its use in the procurement, development and qualification of long lead time equipment for a new $multi million biologics manufacturing facility.

Managed international project teams, to ensure compliance with Sarbanes-Oxley requirements for key IT Data Centres. Developed business performance improvement processes for IT Data Centres.

Built and led a successful team that was instrumental in safeguarding the organisation’s compliance with Sarbanes-Oxley requirements, in support of sanofi-aventis listing on the NYSE.

Established and led a focussed team to develop a landscape for key business processes. Led management endorsement, enabling a cost base reduction through implementation of harmonised tools across key Data Centres.

Challenged existing practices to rapidly identify critical risks to the transition of responsibility for a key IT Data Centre, with essential actions to ensure no user impact during the transition period.

Managed the assurance of product/service quality to meet business and legal requirements.

Developed a groundbreaking Quality Management System for Industrial Operations IS, using a three week intense taskforce to address business needs, best practice (ISO standards) and regulatory authority requirements.

Negotiated with, coached and supported development of key stakeholders to drive the instillation of, and adherence to, quality principles within the organisation. Quality principles were incorporated as part of normal business practice.

Engaged IS leadership in the implementation of customer focussed Key Performance Indicators to tackle lack of discipline and control in the application of critical Quality priorities.

Focussed on customer needs and constraints to challenge and then engineer successful validation of IS elements of an SAP implementation for a major production site, enabling streamlined management of manufacturing operations for $bn products.

Provided leadership and oversight to a compliance programme at UK sites, ensuring a consistent approach in accordance with company standards. Assurance of computerised systems’ implementation and maintenance in compliance with regulatory authority requirements.

Successful management, through clear direction, coaching and practical support, of a compliance programme to assure manufacturing operation computer systems conformed to complex US pharmaceutical regulations, enabling retention of product manufacturing licences.

Contributed expertise to the company’s global team for Computer Validation, challenging accepted practices and clarifying business requirements, to establish harmonised standards and drive their practical implementation to industrial sites.

Project management and support to the implementation of the site’s business change strategy.

Managed a multifunctional site team, utilising leadership, follow up and focussed support to ensure rapid resolution of manufacturing and quality compliance issues prior to successful regulatory authority inspections (FDA, MHRA).

Led customers to identify their needs, built a cross-functional team to deliver a practical, scaleable Project Management process which enabled the organisation to identify and focus on key business improvement projects with effective resource management.