Susan has extensive experience of active pharmaceutical ingredient (API) manufacturing and testing, gained over nearly 30 years.
She has held Senior Quality Management roles in a major pharmaceutical company, serving on Manufacturing Site Management Teams and the Manufacturing Division Quality Executive Team. She has provided input into several strategic quality reviews plus implementing the attendant organisational changes.
Susan has extensive experience of quality management, through representing Actives Sites’ input in developing the Quality System for a major pharmaceutical company and in leading a fine chemicals company to ISO9002 accreditation. In the second case, Susan wrote the quality manual and SOPs for the site.
An early convert to Quality Improvement, Susan has studied various programmes, including Crosby Quality, Total Quality Management, Lean Sigma, 6 Sigma, Accelerated Change Management, and tries to combine the best elements of each in finding a solution to a particular problem.
Susan has been a member of several internal international auditing /assessment teams and has experience of auditing for GMP, GLP and GDP in UK, Europe, India, Singapore, Dubai, Mexico, Panama, Costa Rica, Puerto Rico and USA.
Susan has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. She has also prepared import/export teams for MHRA WDL inspections. She has extensive experience of being the lead spokesperson during major regulatory audits.
Susan is interested in personal development of quality professionals, and developed a career assessment tool, which was used across the actives manufacturing group. She also mentored many younger members of the quality group, helping them with their career choices