Principal Consultant at Three Circles Consulting Ltd
Crewe, United Kingdom
Principal Consultant at Three Circles Consulting Ltd
Crewe, United Kingdom
Action and goal driven Change Manager, with a track record of delivering organisational change through the realisation of value adding processes. Displays strong leadership and influencing skills with a focus on delivery to meet customer needs and service standards.
Key Skills: Leadership, Inflencing & Interaction, Challenging, Customer Orientation
Quality Management, Supplier Auditing, Compliance Auditing.
Project Management, System/Process implementation and enhancement.
GMP, GAMP, 21CFR11, EU GMP Annex 11.
ISO9000:2000, ISO12207, ITIL, Sarbanes-Oxley IT controls.
Education and Learning package development and delivery.
(Pharmaceuticals industry)
November 2006 — Present (2 years 1 month)
We provide consulting and support for business change and improvement, underpinned by our Core skill areas of Quality Management, Project Management and Education & Learning:
• Providing a fresh perspective to your business to ensure that customer expectations are well understood, consistently and measurably addressed,
• Impartial assessment of existing systems or ways of working, identifying opportunities for business growth,
• Establishment, management and enhancement of your key business processes,
• Supplier auditing and compliance,
• Identification and delivery of appropriate learning to support business change.
(Privately Held; 1001-5000 employees; Pharmaceuticals industry)
June 2008 — October 2008 (5 months)
Scoping study to define project objectives, scope, financial and resource investments, stakeholders, cultural change requirements, validation strategy and plans for implementation of an Enterprise Asset Management application to a manufacturing site.
Business Process Mapping for maintenance and calibration activities, simplifying and streamline processes to ensure their added value to the manufacturing operation.
(Privately Held; 1001-5000 employees; Pharmaceuticals industry)
April 2007 — May 2008 (1 year 2 months)
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.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
July 2005 — October 2006 (1 year 4 months)
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.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
May 2003 — July 2005 (2 years 3 months)
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.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
September 2001 — May 2003 (1 year 9 months)
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.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
March 2001 — September 2001 (7 months)
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.
(Public Company; 10,001 or more employees; RPR; Pharmaceuticals industry)
June 1997 — February 2001 (3 years 9 months)
(Public Company; 1001-5000 employees; Pharmaceuticals industry)
August 1992 — May 1997 (4 years 10 months)
Sailing, new technology, Linux