• Manage the Customer Focus Quality Teams across Australia, Malaysia, Switzerland and the USA. Team includes:o Global Complaints and MDR/Vigilance reporting teamo Post Market Surveillance ando Device Analysis team• Ensure compliance to regulations including 21CFR820, 21CFR803, ISO 13485, Med Dev 2.12, AAMI CI86, and EU MDR.• Monitor operational metrics and facilitate process improvements for efficiency• Trackwise development and integration with business processes

• Manage the CLTD CAPA program to ensure compliance to regulations (21CFR820 & ISO 13485)• Support CAPA programs at regional manufacturing sites (Boulder and Mechelen)• Facilitate the global quality hold and recall processes• Coordinate regional communications for CAPA related actions• Lead the CAPA team with 3 direct reports, promoting process improvements to increase productivity and reduce CAPA investigation cycle time

• Manage a TGA/FDA accredited laboratory for the analysis of raw materials and finished products (prescription and OTC). • Responsible for quality system compliance to PIC/S, TGA, 21CFR211, ICHQ1 and ISO9001 regulations.• Manage a team of 25 staff including teamleaders, chemists, microbiologists, equipment support staff, sampling officers and laboratory assistants.• Monitor the monthly budget and cost recovery for the quality control department• Ensure a high level of GMP compliance within the department while maintaining focus on continuous improvement.• Maintain the quality control department in a compliant auditable state• Conduct internal audits of quality and production areas• Coordinate the setup and execution of the stability program to ICH standards• Manage the CAPA program to ensure continuous improvement within the quality and production areas• Coordinate computer systems validation of Quality Control systems, including the “Waters Empower II” validation project• Ensure a safe working environment as chair of the safety committee• Supervise the release for sale of products through SQL*LIMS and SAP systems• Prepare environmental monitoring programs for the production area • Oversee the update and approval of SOP’s, LP’s and test methods• Design training programs for the quality team to ensure competency• Investigate deviations in the quality control and production areas• Recruitment and termination of quality control staff• Prepare monthly presentations on quality department statistics such as monthly spend, recovery, cycle times, headcount justification, lean projects, validation projects and capital purchasing.

• Analysis of finished products for release using HPLC (chemstation) and ICP. • Analysis of stability samples and updating stability trials according to protocol.• Analysis of raw materials using standard bench techniques including NIR, FTIR, titrations, UV/Vis, GC, TLC and polarimetry.• Data management and Report writing using LIMS • Troubleshooting and Preventative maintenance of HPLC and GC systems.• Product ordering and goods receipting for the Quality department using SAP.• Perform routine safety audits throughout all departments within the company as a safety committee member. • Ensure laboratory safety standards are met as laboratory safety representative.• Investigation of OOS results keeping within strict company SOPs.• Perform method development and transfer validation projects.• Calibration and Qualification of laboratory equipment.

• Analysis of raw materials and finished products using Waters HPLC with Empower software.• Troubleshooting instrumentation issues.• Standard bench chemistry techniques used in the analysis of raw materials, including IR, Karl Fischer, UV, TLC and titrations. Some analyses include working in a clean GMP area

Sydney Olympics drug testing