- Provide daily leadership to site investigators supporting Manufacturing, QC, and Engineering
- Ensure investigations meet CGMP, ICH, Health Canada, and corporate standards
- Oversee and improve deviation, CAPA, and change-control lifecycle management
- Lead investigations using structured tools: RCA, 5-Why, fishbone, fault tree, data analysis, and interviews
- Assess product and equipment impact for deviations and contamination events
- Develop and document CAPAs, evaluating their effectiveness over time
- Overseeing and Executing Supply Chain Strategic Direction
- Implement and oversee new Sales and Operation Planning (S&OP regimen.
- Establish and maintain measurable performance metrics for all levels of procurement activities to include but not limited to supplier performance, supplier quality, internal order placement performance, buyer activity levels, financial performance, and material shortage elimination