- – Provide legal and strategic advice on regulatory processes and compliance matters.
- – Draft and review decisions, orders, and notices to uphold administrative law principles.
- – Analyze legal issues and prepare memos while managing external legal counsel as needed.
- 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
- – Manage staff hiring, training, scheduling, and performance evaluations.
- – Oversee daily operations, ensuring smooth service and resolving customer issues.
- – Control inventory, budget, and expenses to maintain profitability and efficiency.