Lynne joined Broughton in 2009 continuously improving quality management systems while making sure products meet safety and quality assurance standards.
- Over 20 years’ of experience in the field of healthcare, pharmaceuticals, medical devices, and nicotine industries with a focus on Quality Assurance and GxP “good practice” guidelines within regulated environments and maintaining compliance
- Inspiring the teams to appreciate the benefit of Quality culture, right first time, process excellence and teamwork, bringing new ways of quality working to the ever changing industry and technology
- High-level standards of investigation, technical troubleshooting, problems, solutions, corrective and preventive action and client satisfaction
- Extensive regulatory inspection experience, hosting FDA, MHRA and client inspections for Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) facility compliance
- Leading the quality assurance teams at Broughton as Quality Director
Lynne Hessel is our Quality Director at Broughton with twenty years’ of experience within the healthcare industry. Her educational background includes a BSc (Hons) degree in Chemistry from the University of Huddersfield.
Lynne progressed her career from an analytical chemistry role into quality assurance, working for several years at Johnson & Johnson within the microbiological laboratory as Quality Team Leader and later as Quality Manager ensuring compliance to ISO 13485 requirements for a quality management system within the Medical Device Directive (MDD). Focused on productivity and efficiency, Lynne enjoys the challenge of continuous improvement and progression of processes and systems.
Joining Broughton in 2006 as Quality Manager Lynne has built a scalable quality system and site quality teams to ensure compliance is continuously maintained.
Lynne has hosted many Food and Drug Administration (FDA), and Medicines & Healthcare products Regulatory Agency (MHRA) inspections during her tenure for pharmaceutical and veterinary products.
Collaborating closely with clients Lynne and the quality teams deliver quality assurance through effective systems; QC batch release using Laboratory Information Management System (LIMS), client and regulatory inspections, quality assurance self-inspections, corrective and preventive actions, documentation systems, investigative problem solving and meeting client expectation.
Lynne is enthusiastic about people, inspiring team members with a forward-thinking approach to the ways in which we work, whilst adhering to the strict GxP guidelines of quality and compliance. With the right people having a quality attitude then quality and exacting standards follow.