Management Team
Caroline Gibson (née Gasson)
Caroline is a Compliance Specialist with 28 years experience in the Healthcare Sector and related industries. She has extensive management, R&D and Quality Assurance experience spanning GCP, GLP, Computer Systems and Pharmacovigilance compliance. Caroline has performed many types of audit and held QA management and global QA Director positions.
However, as well as a vested interest in quality, Caroline is a successful entrepreneur and, therefore, fully understands business challenges and constraints. In 1999 Caroline identified the need for specific software within Research Quality Assurance departments and became one of the two co-founders of AMG IT Systems Ltd., which successfully developed, sold and supported QAAD – the Quality Assurance Audit Database, which has installations in over 50% of the Top 20 Pharma companies. Caroline had many responsibilities, whilst at AMG IT systems Ltd, including the Quality Programme and oversight of validation procedures. In 2007 Caroline sold her majority shareholding in AMG IT Systems to MasterControl Inc.
In 2008 – Caroline co-founded Omnia Quae Ltd.
With her business management, QA expertise and practical knowledge of Validation, Caroline is able to understand and assist in many GXP activities, but also understands the business needs/constraints and customer/QA interfaces. She can fulfil the role of Auditor, Compliance Manager or Director for compliance and audit activities as well as advise on or manage validation projects.
Education: BSc (Hons) in Applied Biology, specialising in Pharmacology and an MSc in Pharmaceutical Medicine.
Don Gibson
Don Gibson is an I.S professional and has spent 12 years working in technology in Investment Banks. An IS professional for 5 years, he holds an active CISSP, and has specialised in Portable Media Management, Blackberry Devices, Data Centres, and third party I.S assessments. He helped make his last bank compliant to the Sarbanes-Oxley protocols as well as obtaining ISO9001 certification.
Leaving University in 1997 with a BSc in Business and Environmental Sciences, Don went straight into working in Investments banks, starting in the IT section of JP Morgan, before going to Dresdner Kleinwort Benson. Within a year he was running the support for the Equity Capital Markets section, and won the trust and admiration of the traders by designing a support model around them and their needs – a totally alien concept to the bank.
Headhunted to join Salomon Smith Barney (later Citigroup) in January 2000, Don worked within the support structure until 2003, when he jumped across into an entirely new section, with global remits. Information Security was the new frontier, and within a year Don had a CISSP qualification (normally something awarded after 3 years), and a seat to see exactly how Information Security could help a business, and exactly how it should not be utilised.
In 2006 he was recruited within Citigroup to be the Information Security Officer for the entire European Equity Trade floor. He left the bank in 2007, to concentrate on running the family home, before setting up Omnia Quae in 2008.