Manager, External Quality

at  Omniabio

POSITION SUMMARY:

As Manager, External Quality at OmniaBio, you will be responsible for designing, implementing and managing the external quality program within a cell and gene therapy manufacturing facility. You will design, implement and manage the supplier and material management program. The role will liaise closely with all functions operating in the Good Manufacturing Practices (GMP) environment including supply chain, manufacturing quality, quality compliance, quality control (QC) and manufacturing science and technology (MSAT). You will be a key member of the Quality management team.

REQUIREMENTS:

• Bachelor of science degree in science or engineering.
• 8-10 years of equivalent industrial experience.
• Must have knowledge of management or outsourced activities.
• Practitioner of risk management and comfortable in the use of risk analysis tools.
• Must have working experience in the delivery of biological products for commercial supply.
• Excellent understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and QA principles.

• Maintains a high level of expertise in GMP supplier oversight with respect to cell and gene therapy manufacture.
• Designs, creates, implements and maintains the supplier qualification program.
• Designs, creates, implements and maintains the quality agreement program.
• Designs, creates, implements and maintains the vendor audit program at OmniaBio, including audit scheduling and optimization.
• Designs, creates, implements and maintains the Materials Review Board program in consultation with MSAT and QC teams.
• Provides input to the management review of the quality program, identifies continuous improvement opportunities and delivers on remediations as a key member of the Quality Assurance (QA) team.
• Develops test specifications and testing strategies for incoming materials in collaboration with MSAT and QC teams.
• Identifies risk management strategies for key supplier and critical materials in collaboration with supply chain and procurement business partners.
• Identifies critical suppliers and service providers, and develops and maintains app ropriate oversight programs in collaboration with QC, Manufacturing and other functions.
• Reviews and approves deviations, corrective and preventative actions, change controls, and other quality-related documents as required.
• Ensures GMP is embedded in all manufacturing-related tasks.
• Engages and supports the OmniaBio Operating Model continuous improvement philosophy.