Experience

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  Felix schoeller group

  Sept 1997 - May 1999

  Project leader

  Management of laboratory and full scale trials (extrusion coatings for digital imaging).

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  Abbott

  May 1999 - Jan 2003

  Tender submission to Primary Care Trusts. Management and promotion of diabetes diagnostics to hospitals and clinics. • Introduction of new diabetes diagnostic products to manufacturing.• Transfer of manufacturing equipment and validation of products to new facility.• Creation of validation protocols, procedures and SOPs.• Complaints investigation and Corrective and Preventative Actions (CAPAs).• Execution of Project FMEA and equipment risk assessment.• Identifying, justifying & completing numerous Cost Improvement Projects.

  • Territory Manager

    Oct 2001 - Jan 2003

  • Snr Scientist

    May 1999 - Oct 2001
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  Owen mumford ltd

  Feb 2003 - Feb 2005

  Project engineer

  • Management of NPI projects from feasibility to production stage, including management and coordination of engineers and production operatives during DFM / design verification stages.• Introduction of Kanban, single piece flow and pull systems in the drive towards lean manufacturing. • Jig, fixture and semi-automated equipment specification with ‘Poke Yoke’ design. • Dealing with Sales & Marketing to ensure their new device requirements were met in ‘delighting’ the end customer.• Assembly cell layout design to reduce assembly steps including introduction of manual-load, automated assembly machines.• Department manager deputy during absence. Show less

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  Oxford biosensors

  Feb 2005 - Feb 2006

  Process engineer (12 month contract)

  Medical devices (cholesterol biosensor) • Responsible for the design transfer activities of the cholesterol test strip biosensor using flat bed printing technology. • Facilitator in the scale-up of new products to manufacturing stage, with new processes and equipment.• Analysis of process monitoring data for trends and implementation of SPC.

• 

  Advance accounting

  Feb 2009 - Feb 2013

  Self employed

  My own accountancy business to accommodate family commitments. CIMA cert. (Business Accounting & Enterprise Operations); ICB Qualification.

• 

  Owen mumford ltd

  Mar 2013 - Feb 2019

  • Leading cross-functional teams in the management of all projects within manufacturing. Engineering modifications, continuous improvement programmes, new product introduction, process streamlining and cost reduction initiatives. • Close liaison with compliance and regulatory management to ensure that alterations to the process are well planned and executed to deliver changes with minimal risk impact. Good working relationships across departments has enabled me to deliver 'right first time' solutions to technical production issues. • Coordination of trials / design verification for new product transfer.• Responsible for commercial agreements and the communication of process change proposal documentation.• Allocation and monitoring of project costs within CAPEX budget constraints. • Implementation of Lean within supply chain: OTIF improvement and lead time reduction (TPM, kaizen and process flow optimisation to tackle stock delays)• Completion of quality compliance documentation within a highly-regulated environment from the implementation of change control through to risk assessments, investigation reporting, CAPA and exceptions.• Assuring compliance of all projects to GMP, FDA & ISO standards. Show less • Responsible for the capacity expansion of single-use lancing devices in accordance with ISO 13485 / FDA 21 CFR 820 & part 11 standards and cGMP regulation. • Process optimisation of injection moulding machines using Moldflow analysis, DOE and Process Capability / Performance Cpk/Ppk using statistical software (Minitab)• Implementation of Equipment Qualification documents (URS/TS/DS, FAT & SAT) during commissioning stages (moulding, assembly, measurement and packing equipment).• Management of FAT & SAT activities to ensure equipment meets specification.• Risk based, streamlined approach to validation planning including the initiation and execution of change control, FMEA and associated documentation (VMP, VPs, VSR)• Creation and maintenance of the Site Validation Master Plan (SVMP) including re-validation assessments (NCRs / Change Control reviews). Show less

  • Project Manager

    Jun 2016 - Feb 2019

  • Validation / Projects Engineer

    Mar 2013 - Jun 2016
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  Summit medical group ltd

  Feb 2019 - Jan 2022

  NPI Projects including class III Medical device Regulatory program management: MDR program for all product portfolios • Implementation of a Project Management Governance Framework to provide a gated pathway from project concept to launch.• Responsible for Commercial and Technical Risk Management through project- and Programme- risk registers as well as tools and templates to demonstrate continued Business Case justification• Full responsibility of design controls documentation from feasibility through each gated design review to product launch (Design Specification Matrix, Design History and Risk Management Files, dFMEA, V&V.• Overall responsibility of programme resourcing and prioritisation (both NPD and pan-group projects).• Regular Programme timeline and budget KPI reporting to the Board of Investors. Show less

  • Head of New Product Introduction

    Nov 2020 - Jan 2022

  • Program Manager

    Feb 2019 - Nov 2020
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  Sartorius

  Jan 2022 - now

  Leadership of the PMO for regional & complex global projects including lab instrumentation, lab filtration, purification, separation & microbiology, cell culture media, software connectivity projects and medical devices Set up and Led 2 regulatory compliance programs - MDR (EU) 2017/745 & IVDR (EU) 2017/746 in addition to a Technology enablement project for new medical device

  • Innovation PMO Manager (Global) Lab Products & Services

    Sept 2022 - now

  • Regulatory Programme Manager MDR | IVDR

    Jan 2022 - Sept 2022