- 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 process design and scale-up, ensuring alignment with client needs and lifecycle
- – Enforce best practices for technology transfer and conduct process engineering analysis
- – Collaborate with cross-functional teams to establish robust commercial processes and controls
- Provide guidance and oversight to QC microbiology and environmental monitoring staff.
- Administer the environmental monitoring program throughout the facility.
- Ensure training of microbiology and environmental monitoring programs is up to date.