Quality Assurance and Regulatory Affairs Manager
Since October 2014
Manage a team of seven with a budget of £400 K. My team includes QA, RA, QC and R&D for our product portfolio. This portfolio includes medical devices in Class I, IIa and IIb (93/42/EEC), cosmetic products (EC 1223/2009) and biocidal products (EC 528/2012) . We are accredited to ISO 9001 and ISO 13485 and manufacture cosmetics to GMP (ISO 22716). Our medical devices comply with ISO 14644, ISO 11607, and ISO 14971; and are sterilised by a number of methods ISO 11135 or ISO 11137 or ISO 17665. I manage a remote team in China that carries out supplier audits. We have a supplier communication and education programme and use a variety of quality improvement techniques to upskill suppliers to improve the quality of incoming products. This is part of a strategic approach to our CAPA programme with objective reducing non-conformancies, complaints and FSCA in the medium to long term.
May 2012 --- October 2014
Providing support to companies in the food, pharma and diagnostics industries.
November 2010 --- December 2011
Provexis specialises is the discovery, development and licensing of functional food, medical food and dietary supplement technologies. Reporting to the Chief Operating Officer. Manage a multi-disciplinary team of scientists isolating active ingredients in plants Introduced standardised project planning tools across the company Introduced Objective Setting and Review tools across the company Introduced a Quality Management System into the team, SOPs and GLP for the laboratory. Introduced validation for chemical and microbiological methods Team manufacture trial materials to GMP standard for use in Phase I trials for circulatory diseases. The sponsor for Provexis plc first Phase II clinical trial on a nutraceutical treatment of Crohn’s disease Negotiation of Clinical Trial Agreements, preparation and monitoring of budgets for trials. Review and management of Investigators against agreed objectives for the trial Selection and initiation of new trial sites Monitoring of trial site recruitment and development of tactics to improve recruitment rate Successfully completed the company’s first MHRA inspection in March 2011, where our Annual Safety Report was commended. Set up an independent Data Monitoring Committee fro the Crohn’s study Carried out interim analysis on the study twice – wrote the statistical analysis plan Submission of amendments to Ethics Committee
R&D Group Manager
May 2008 --- November 2010
Manage a team of 12 including chemists and microbiologists.Responsible for a budget of $2.5 M. We design production processes and formulations for the manufacture of antibiotic discs used in antimicrobial susceptibility testing. We also provide a project managed process for the development of quality assured material for clinical trials of antimicrobials. Designed and developed a system for dealing with hazardous spills that has the acronym SEE - Spill, Evacuate, Evaluate. This is being rolled out across Thermo Fisher Scientific Microbiology Division. Introduced the use of NFPA "Right to Know" labels as a system for communicating to our colleagues the degree of risk associated with an experiment. Pioneered the use of 5s for improving efficiency and safety in the R&D labs. I was an invited speaker at the WHO sponsored First International Conference on Cronobacter spp. in Dublin in January 2009
September 2003 --- May 2008
Reporting the Vice President for R&D (Innovation) and the R&D Manager (Operations Support). Six direct reports, and six indirect reports on project in China. Developed a three stage statistics course called "Objective Decision Making" (ODM) specifically aimed at the needs of microbiologists. R&D, QC and QA staff were all trained in ODM. Developed and implemented a project management system that delegated responsibility and empowered junior staff. Through the use of ODM and good project management we were able to reduce product development time down to 6 months from the previous 2.5 years. This allowed us to brig Oxoid's Chromogenic MRSA Agar from design to launch, including a clinical trial, in six months. This product is Oxoid's largest selling product, with sales of >$10 M per year. Managed the Manufacturing Technologies Group (MTG). This covered support and process improvement for the manufacture of powders, sterile liquids, aseptically manufactured products, and two product lines of FDA Class II devices. Introduced the use risk analysis tools in to the design and monitoring of processes for the manufacture of antibiotic discs and test strips. This included Failure Mode Effect Criticality Analysis (FMECA) and Hazard Analysis Critical Control Points (HACCP) for monitoring. Using the most heat resistant organism isolated from our powdered product we were able to calculate the F0 for autoclaving processes. This reduced the manufacturing time by more than 25 %, reduced the energy costs, and improved the quality of the final product Introduced Statistical Process Control (SPC) charts for in process monitoring of product quality for a Class II blood culture test. Improvements reduced total failures from 25 batches per year, saving $220 K per year. Introduced SPC charts for pH together with an appropriate spreadsheet to the poured plated facilities. This method saved more than $500 K in the first year in scrap in one facility.
Research Scientist - biochemical test strips
January 2001 --- September 2003
Designed biochemical identification test strips for Enterobacteriaceae. Designed numerous chromogenic culture media, including Druggan-Forsythe-Iversen (DFI) Agar for Cronobacter species (Enterobacter sakazakii) and Brilliance MRSA Agar. Filed IP for the use of Inhibigen glycosides for therapeutic use.
Research Scientist - food microbiology
March 1997 --- January 2001
Worked on stressed Salmonella and ways to improve resucitation and enrichment, resulted in SPRINT Salmonella. Filed IP for improvements to resuscitation of injured cells. Designed a non-carcinogenic aminopeptidase test that is the basis of OBIS range. This project was carried out to replace an OEM with £30 k per year. Sales peaked £250 K per annum within 5 years. Filed IP for non-carcinogenic amino-peptidase tests. Designed a template for scientific poster to brand Oxoid R&D. This allowed customers to readily identify Oxoid posters at conference. This template was used until a rebranding exercise was carried out by Marketing Communcations in 2008.
Research Scientist - autocytotoxic compounds
August 1995 --- February 1997
Reporting to the R&D Director of Unipath Limited. Synthesis and characterisation of autocytotoxic compounds (Inhibigens) for improved specificity of isolation methods for injured Salmonella from food samples.
Quality Control Manager
August 1994 --- July 1995
Reporting to the Vice President for Germany at a site that had been commissioned to manufacture ready-prepared culture media in June 1992. I managed a team of three. Introduced new batch manufacturing record documents, QC documentation and QC SOP system for compliance to ISO 9001. Designed a new batch manufacturing record to comply with the requirements of ISO9001. Reorganised the QC function to be more proactive in dealing with potential quality issues through the introduction of a Critical Action Team and the use of risk analysis methods. Reduced complaints from one per 200 plates made to one per 1000 plates made within a year, even though production volume doubled during that time frame.
January 1994 --- August 1994
Reporting to the Marketing Director, Managing the technical services function with a team of six for Western Europe, excluding UK. Lead team to design and construct a new complaints handling database in Lotus Notes. The new complaint handling system implemented before transfer to QC manager position. Implemented SPC charts for monitoring complaints for major product groups. Trouble shooting the manufacturing process for aseptically filled culture media. Introduced the use of risk assessment tools. FMECA and HACCP to analyse processes and to focus resources on those issues that would have the greatest impact on the quality of the product, and made most effective use of capital. Designed Oxoid's first dual chromogen agar for the detection and differentiation of E. coli and coliforms. Filed a patent on the use of autocytotoxic compounds in culture media (Inhibigens).
Technology Transfer Scientist
December 1991 --- December 1993
Reporting to the Operations Director, managing a team of three. Responsible for the training, SOP writing, equipment procurement and successful implementation of new processes for manufacturing cell-culture media and associated products in to the European site. Design of filtration trains for sterile filtration for aseptic manufacture of cell-culture and animal sera
February 1987 --- December 1991
Redesigned the inefficient powder manufacturing process. The increase in capacity resulted in a saving of $400K in capital equipment when sales expanded due to the sale of the Gibco brand to BBL and transfer of some manufacturing to the UK. Developed a modified version of Dulbecco's MEM that gave a > 30 % in yield of SP2 in static culture. Used Taguchi design of experiment methodology to improve the yield on Mycoplasma spp., Erysipelothrix rhusiopathiae and Haemophillus spp. for vaccine manufacture. Designed the method and wrote SOP for investigation of contaminants in filter sterilised aseptically manufactured cell-culture media.
Quality control technician
June 1985 --- March 1986
Ph.D. in Pharmacy from University of Brighton in 2007
M.Sc. in Quality Management from University of Paisley in 1993
B.Sc. (Honours) in Food Science from University of Strathclyde in 1985
Training and Certification
Lead Auditor ISO 13485 Certification