Global Head Of Quality
Rutherford, New South Wales, Australia
As the Global Head of Quality I reported directly to the Managing Director and I was responsible for the management of 6 QA staff, 8 QC staff and 3 validation staff members. I was a member of the Senior Management Leadership Team and I advised on all aspects of international GMP and Quality Compliance to all levels in the company, globally and including third party stakeholders. I was charged with managing the lead up preparations and I hosted inspections by the FDA, TGA and APVMA regulatory authorities. I formulated, developed and implemented a robust CAPA plan to address deficiency findings to ensure continued facility GMP compliance and approval. In addition, I was accountable for the quality assurance of all products manufactured by Jurox on a global scale. This included overall responsibility for deviation management, change management, non-conformance management, complaint handling, release for supply and CAPA systems. Implemented quality risk management principles and effective root cause analysis to problem solving. Furthermore, I implemented a quality continuous improvement programme across all relevant departments including Production, Engineering, Quality and Research and Development.