Newcastle Upon Tyne, England, United Kingdom
With 40 years in quality, engineering, and manufacturing — including 25 years as Quality Assurance Manager at Parker Hannifin's Bioscience Filtration site — I led quality assurance strategy across multiple sites, driving operational excellence in a cGMP environment. I hold a Six Sigma Black Belt (Newcastle University) and have applied Lean and Six Sigma methodologies throughout my career to eliminate waste, reduce variation, and build quality cultures that last - a result of disciplined process improvement, rigorous compliance, and a team-first approach to continuous improvement. Key areas of expertise: • Quality Management Systems: ISO 9001, ISO 13485, ISO 14001, ISO 22000, ISO 45001, cGMP, and 21CFR Part 820. • Six Sigma & Lean: Black Belt certified, process mapping, waste elimination, 8D problem solving • Regulatory compliance & auditing: internal, supplier, and customer audits • Cross-functional leadership: team development, HR management, performance improvement • Strategic QA: KPI reporting, corrective/preventive action, management reviews Beyond my day role, I write on leadership, decision-making, and organisational performance — exploring how smart people make better choices under pressure. My work has been published in Quality World (Chartered Quality Institute) and featured on my blog, Fulcrum.blog. Open to senior QA leadership, Director of Quality, or Head of Quality Assurance roles in life sciences, bioscience, or regulated manufacturing.
Leading the Quality Assurance function across all sites in a highly regulated bioscience filtration environment. Key achievements & responsibilities: • Led QA strategy and operations across multiple sites, ensuring full cGMP compliance and alignment with business goals • Guided the facility to win the UK's Best Factory award — a flagship recognition of manufacturing excellence • Developed and deployed cross-divisional Six Sigma and Lean Improvement projects, reducing waste and process variation • Drove continuous improvement culture throughLean waste elimination, process mapping, and cross-functional collaboration • Ensure ongoing compliance with ISO standards, cGMP procedures, and regulatory quality requirements • Completed Improving Organisational Effectiveness and High Performance Work Team training programmes • Managed internal and external audit, corrective/preventive actions, and non-conformance investigations • Presented quality KPIs and data at Management Business Reviews, influencing strategic decision-making Published contributor to Quality World Magazine (Chartered Quality Institute) on quality and continuous improvement topics
Built and led the QHSE function from the ground up to a greenfield facility — growing from an empty warehouse to an organisation of over 100 employees. Key achievements: • Attained ISO 9002, ISO 14001, and ISO TS 16949 (automotive) certification from scratch • Designed and implemented the OHSAS 18001 health and safety management system • Reduced PPM defect levels through a robust new product introduction system (APQP-based) including Kaizen events • Led the EFQM Business Excellence project using benchmarking and balanced scorecard methodology • Delivered productivity, quality, and safety improvements through ergonomic job redesign • Responsible for all quality, health & safety, and environmental matters across the site • Conducted Business Excellence training, audits, accident investigations, and environmental risk assessments
Managed quality assurance for complex turnkey combined cycle gas turbine power station projects, from initial planning through to completion against strict deadlines and technical specifications. Key responsibilities: • EstablishedISO 9001 and ISO 14001 procedures for head office an construction sites • Contributed to winning the Engineering Council Environmental Achievement Award and he Business Commitment to the Environment Award • Planned and conducted internal and external quality management system audits • Managed the QA interface with clients, partner companies, and vendors to determine inspection levels within resource and time constraints
Analytically estimated steelwork fabrication costs and planning work-hour estimates, for the assembly and erection of offshore oil and gas modules.
Served a EITB and NEEEA apprenticeship: 1 year engineering training and 3 years broad experience of main equipment design, testing, inspection, planning, manufacturing and commercial activities.