Tony Shaw

Experience

• 

  GSK

  Mar 1995 - now

  Lead a team of Project and Change managers delivering transformational projects within and across R&D. These have included (but not limited to)- Accelerating Submissions, delivering industry bench-marked upper quartile performance for 1st submissions by optimising processes, WoW and behaviours/mindset- R&D Governance Process Improvements, identifying and implementing changes that make R&D more agile and efficient- European Continuity of Supply regulation implementation to ensure continued supply of critical medicines to patients in the EU- Medical Engagement and Excellence Organisation design- MAH changes as a result of Brexit to ensure continuity of supply of all GSK products licensed in the EU Show less Led the Regulatory Business Operations team, a team whose role is accountable for supporting pan-Regulatory projects and initiatives, including:- Provide project management tools, skills, and capability.- Leverage GRA’s internal and external resources with the expectation of conformance and cost-effectiveness.- Lead process improvement with aim toward simple and efficient delivery.- Manage strategy deployment for OCRO’s business objectives.- Maintain compliant and efficient operating standards and key performance indicators/metrics for all OCRO Functions. - Ensure OCRO “Air Traffic Control” to support governance (prioritization, decision-making, ROI) for Function and matrix team work, projects, and improvements. Show less Managing a wide variety of projects including;- Closure of manufacturing facility in Germany- Transfer of Pharma product manufacture from Italy to Algeria- Product expansion and registration of existing GSK portfolio (47 products) into 50 Least Developed Countries- Continuous improvement activities for department, including standardised WoW and performance management- Delivery of the Supply Chain Transformation programme work-streams for the GSK Production System and Process Robustness- PM for the delivery of the McLaren/GSK strategic partnership Show less - Project planner, manager and PMO for the Site Closure of the Dartford Site.- Developed detailed knowledge of all operational and closure aspects of GMS Primary site including QA, Regulatory, Production, Engineering, IT, Supply & Logistics and impact on Secondary manufacturing.- Developed and owned communication plan, reporting progress, opportunities and issues at senior management levels (Site and above-site GMS)- Leading Site and Above-site steering process, building relationships with & influencing at SLT and above-site (GMS Network Change) levels to ensure project meets targets, manages risks and maximizes benefits.- Developed closure strategy, plans, schedules & reports with Site Leadership team.- Led development of detailed function schedule creation, including defining various breakdown structures to enable analysis, using Microsoft Project.- Integrating Outsourcing and Site based functional closure activities to achieve accelerated project delivery.- Developed and owned Schedule management process (including impact assessment and change control) for the Site Closure team, ensuring risks mitigated and contingencies in place.- Providing project coaching and development to a team of 12 individual Project Managers. Show less - QA Programme Manager for Laboratory Systems, Analytical Validation & 3rd Party Service provision.- Managed the QA Support Cost Centre with an annual budget of £700K. - Project manager for QA/TD equipment procurement & strategy ensuring stakeholder requirements agreed, best value suppliers identified, developing relationships, creating contracts & service level agreements, managing performance and issue resolution.- Successful divestment of UK/Ireland laboratory services project to Sodexo. GMS owner for defining QA strategy, leading due diligence activities, creating technical/ service level agreements.- Project manager for Pharmasys Validation project, using an external company to complete validation activities at Dartford. Accountable for all aspects of the contract including cost, issue resolution, progress reporting and contract termination. Show less - Successfully recruiting & leading both the QA and Validation teams in the implementation of the MERPS Project for both GMS Dartford and Beckenham.- Defining the Business Case, scope and Project Management Plan for QA and Validation, ensuring project timelines were achieved on time, in full.- Defined quality requirements for all functions, influenced stakeholders across and above-site to implement pragmatic and cost-effective yet compliant processes.- Developing option studies, including benefits mapping, business cases & project proposals, to maximize benefits whilst minimising cost.- Developing and owning the Risk Management, and Change Control processes for the project.- Developing and owning cutover schedule ensuring continuity of supply. Show less - Defining strategies and priorities within and across highly pressurized QA teams, implementing and embedding OE Value Streams in QA.- Leading a multi-disciplinary team of 3 shifts/24 people including Quality Officers, Team Leaders and Analytical Technicians for critical supply APIs.- Successfully leading project to migrate laboratory to new facility ensuring continuity of service, at lowest cost, to all stakeholders including Operations and Supply & Logistics.- Successfully outsourced stability sample storage to external facility, identifying preferred supplier, building relationship and managing critical requirements including capability, technical agreements and cost, to new facility at Cirrus. - Identifying improvement opportunities & resolving issues using OE tools and implementing corrective and preventative actions, e.g. reduced testing/receipt of materials on CofA, flow improvements, standard work. Show less

  • Business Transformation Office Lead

    Dec 2018 - now

  • Business Operations Director/Lead, Global Regulatory Affairs

    Nov 2016 - Nov 2018

  • Global Regulatory Affairs, Project Management Office, Project Manager

    Feb 2014 - Nov 2016

  • Network Change Project Manager

    Jul 2011 - Jan 2014

  • Closure Project Planner/Manager/PMO

    Mar 2009 - Aug 2011

  • QA Support Manager

    Dec 2007 - Mar 2009

  • MERPS Implementation Quality Assurance and Validation Project Manager

    Jun 2006 - Nov 2007

  • QA Value Stream Team Manager/Quality Compliance Team Manager

    May 2003 - May 2006

  • (Senior) Laboratory Technician/Laboratory Supervisor

    Mar 1995 - Apr 2003