Experience

Industrial Technology Systems Ltd (ITS Ltd)

• United Kingdom
• Automation Machinery Manufacturing
• 1 - 100 Employee

• Regulatory Compliance Services Manager

  • Oct 2020 - Present

  Responsible for growing ITS regulatory compliance services group. Current focus is the delivery of a portfolio of on-line Regulatory Compliance training courses covering GAMP 5, 21 CFR Part 11/Data Integrity, Understanding Validation, IT Infrastructure Controls and Compliance, SOP writing, GMP etc. Other areas of activity include broadening the range of Validation and Compliance services offered and actively promoting ITS' capability aligned to Digital Transformation building on ITS' deep technical knowledge and experience in Automation, Vision and Business systems solutions.



Jennifer Thompson Strategy & Solutions Ltd

• IT& Computer Systems Compliance | Business Development & Innovation | Digital Transformation

  • Jan 2019 - Present

  My key areas of expertise are: 1) Business strategy, business development, innovation support and strategic partnerships for science, technology and engineering based businesses and 2) IT and Computer Systems Validation and Compliance for the Pharmaceutical, Biotech and Medical Devices sectors. I provide tailored consultancy, project management, strategic relationship development and business support services for SMEs, large corporates and in Higher Education. I also provide specialist consultancy, delivery and training services in Computer Systems Validation (FDA, EMEA, MHRA) and Sarbanes-Oxley IT controls, Risk-based compliance and QA. I am ideally placed to support Digital Transformation projects due to my deep understanding of data management, data integrity & data analytics and regulatory compliance. Recent projects:IT Systems Risk and Compliance: Working for ABB Group IS Risk & Compliance delivering Sarbanes-Oxley IT controls consultancy support for the ABB global compliance programme. Coached IT and Finance staff on requirements for IT Controls and Back-testing reporting and good documentation practice. Conducted quality reviews to ensure risk, compliance and quality requirements were met. Undertook data analysis (Excel) and reporting in response to auditor queries, in order to provide evidence of compliance status.Higher Education: supported the project leads at Hull University in finalising the Strength-in-Places Energy Estuary bid by providing feedback as the bid developed and helping them think through the project organisational structure in a way that would facilitate collaborative working between academics and SMEs in each work stream and ensure good governance and effective reporting.Digital transformation consultancy: worked with a highly-regarded Engineering Company to map its digital and analytical capabilities to the needs of the Pharmaceutical sector.



CPI

• United Kingdom
• Research Services
• 400 - 500 Employee

• Business Development Manager

  • Jan 2020 - Oct 2020

  Responsible for translating the technical capability offered by CPI to a range of clients, effective networking and stakeholder relationship management and enabling the development of collaborative partnerships and effective project delivery.CPI is leading independent technology innovation centre, established in 2004, and a founding member of the UK Government’s High Value Manufacturing Catapult and acts as a catalyst bringing together academia, businesses, government and investors to translate bright ideas and research into the marketplace.



Teesside University

• United Kingdom
• Higher Education
• 700 & Above Employee

• Associate Dean (Enterprise and Business Engagement) | Member of School Executive

  • Mar 2017 - Oct 2018

  In this newly defined Executive Team role in the School of Science, Engineering and Design, I developed and rolled out a business engagement strategy to establish long term strategic partnerships, grow business-related income (>£3.6M per annum), refresh the TU On-line learning in Engineering offer, significantly expand Degree Apprenticeships and improve graduate employment outcomes. This broad remit required extensive engagement at Executive and Senior Management level with SMEs, public sector organisations (NHS, Tees Valley Combined Authority) and large multi-nationals (Siemens, SABIC, EDF Energy), with the Centre for Process Innovation and intermediary organisations (BioNow, EEF, NEPIC). Key Projects and Achievements: • Developed and consolidated the strategic partnership with Fujifilm Diosynth Biotechnologies, establishing a steering group to take forward the implementation plan, negotiated a collaboration agreement with TV presenter George Clark’s social enterprise, the Ministry of Building Innovation and Education (MOBIE) • Led the development of a strategic partnership with Durham Constabulary and significantly strengthened and broadened relationships with Siemens and the Centre for Process Innovation• Set ambitious targets for Knowledge Transfer Partnerships resulting in seven new projects secured in 2018 and a strong future pipeline • Led an academic project team through the successful development and approval of a £0.9M ERDF project to develop regional SME capacity in the Hydrogen Economy supply chain• Developed the Business Engagement Strategy for the £22M New Horizon Centre (a flagship BioSciences Institute launching in 2019) including analysis of Bio-Industry needs. • Contributed to securing Research England funding (£5M) to develop the region's Bio-Economy with York and Hull Universities• Contributed to bids to the value of £4M+ against the Industry Strategy Challenge Fund, Strength in Places and other calls.



Durham University

• United Kingdom
• Higher Education
• 700 & Above Employee

• Head of Partnerships & Engagement | Head of Business Development

  • Apr 2009 - Feb 2017

  Purpose of the role is to bring together business and academics - faciliate relationships and enable a wide variety of interactions including contract and collaborative research, consultancy, access to facilities and equipment, sponsorships of PhD, post-doctoral and research assistant positions, identifying opportunities for engagement through student projects and graduate recruitment and employer engagement to encourage business to invest in High Level Skills Purpose of the role is to bring together business and academics - faciliate relationships and enable a wide variety of interactions including contract and collaborative research, consultancy, access to facilities and equipment, sponsorships of PhD, post-doctoral and research assistant positions, identifying opportunities for engagement through student projects and graduate recruitment and employer engagement to encourage business to invest in High Level Skills



ABB

• Switzerland
• Automation Machinery Manufacturing
• 700 & Above Employee

• Principal Consultanct - IT & Computer Systems Validation and Regulatory Compliance

  • Apr 1999 - Mar 2009

  Specialist in IT and Computer Systems Validation in the Pharmaceutical/Healthcare sector. Expertise in Data Quality, Process Analytical Technology, 21 CFR Part 11, Sarbanes-Oxley etc. Wide ranging experience in the realisation of projects in Manufacturing and R&D across a range of companies both nationally and internationally. From 2002, member of the Management Team with responsibility for leading a team of geographically dispersed consultants. This developed my skills in strategic planning and budgeting. Responsibilities in the Life Sciences leadership team included market analysis, the development of marketing and business growth strategies, the identification and development of new services, revenue forecasting and the monitoring income and profit. Clients included: GSK, Novartis, IBM, AstraZeneca, Amersham Pharmaceuticals, Elan Pharmaceuticals, Hoffman La Roche, Pfizer, GE Healthcare, Pfizer, Lonza Biologics, ABB Headquarters and global sites and others.On return from 1 year maternity leave in 2007 - responsibility for the delivery of complex multidisciplinary projects within ABB Ltd and in the pharmaceutical sector. Examples include:• Contributed to the ABB company-wide Information Services Transformation Programme by consolidating best practice Guidelines and Policies in the implementation and use of Enterprise Resource Planning systems rolled out across all global business units.• Development of a new service offering in Process Analytical Technology to complement existing ABB technology working with business units in Canada, France and the USA.• Market research and subsequent facilitation of a successful 2 Million Euro bid to Enterprise Ireland (Development Agency) for a three-year research project to develop a Process Analytical Technology enabled Process Control System for real time product release of manufactured bio-pharmaceuticals. This involved working with Enterprise Ireland, an academic consortium and industry partners.



Independent Consultant

• Business and Technology Consultant, Germany

  • Nov 1994 - Mar 1999

  I established and grew a portfolio of clients including Bran & Luebbe Gmbh and other technical businesses and startups. This experience developed my businesses development expertise and commercial awareness and strengthened my project management skills.Services provided included: business planning and support, and the scoping, planning and management and delivery of software projects (using 3rd party software developers), and consultancy projects focusing on quality management, regulatory compliance, analytical systems and data analysis and interpretation.



Bran + Luebbe GmbH

• R&D Task Force Leader

  • Jul 1991 - Oct 1994

  R&D Task Force leader responsible for the commercial production of the prototype analyser developed at Ciba-Geigy including establishing the production specifications, assembly and testing procedures and quality assurance processes (compatible with Pharmaceutical sector regulatory compliance requirements). The role involved leadership and management of the interdisciplinary R&D Team [10 people], budget management, internal liaison with the production and marketing teams and engagement with early adopters in industry to deliver pilot projects.



Ciba-Geigy - Pharmaceuticals

• Researcher - Central Analytical Development

  • Aug 1988 - Jun 1991

  Collaborated with an SME to co-develop, test and pilot an innovative mobile analytical system for the rapid identification of raw materials used in pharmaceutical production. The system used sophisticated pattern recognition techniques to reliably identify and classify raw materials in seconds and realising significant cost savings by facilitating just-in-time production in this highly-regulated environment. Collaborated with an SME to co-develop, test and pilot an innovative mobile analytical system for the rapid identification of raw materials used in pharmaceutical production. The system used sophisticated pattern recognition techniques to reliably identify and classify raw materials in seconds and realising significant cost savings by facilitating just-in-time production in this highly-regulated environment.



Max-Planck Institute for Solid State Research, Stuttgart, Germany

• Germany
• Research
• 100 - 200 Employee

• Research Scientist

  • Dec 1987 - May 1988

  Completed research and published on defects in semi-conductors using infra-red spectroscopy techniques. Completed research and published on defects in semi-conductors using infra-red spectroscopy techniques.