The Senior Manager, Quality Engineering provides leadership and governance of Quality Assurance activities related to sterility assurance, validation, equipment qualification and calibration, data integrity, quality risk management, and visual inspection.

Key Accountabilities

• Provide QA governance and strategic oversight for Quality Engineering activities supporting manufacturing and sterile operations.
• Ensure engineering, validation, and inspection activities are aligned with GMP regulations (Health Canada, FDA, EU).
• Act as the QA escalation point for engineering‑related quality risks and compliance issues.
• Ensure Quality Engineering processes are integrated with Quality Operations and Quality Systems.
• Provide QA oversight of the site sterility assurance program, including aseptic processing controls, contamination control strategies, and sterilization processes and validation.
• Ensure sterility assurance a...