OmniaBio: Director, Quality Compliance

About OmniaBio:

OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.

Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.com to learn more.

Reports to:          Vice President, Quality Assurance and Regulatory Compliance

Department:        Quality

Position Summary:

As Director, Quality Compliance, at OmniaBio, you will be responsible for designing, implementing and managing the overall compliance program within a cell and gene therapy manufacturing facility. You will provide strategic and tactical direction on the key compliance programs for OmniaBio. The role will liaise closely with all team members operating in the Good Manufacturing Practices (GMP) environment, along with external stakeholders and regulators. You will be a key member of the Quality Management team.

Responsibilities:

• Maintains a high level of expertise in GMP compliance with respect to cell and gene therapy manufacture and well as all aspects of GMP compliance.
• Designs, creates, implements and maintains the corrective and preventive action (CAPA) program.
• Designs, creates, implements and maintains the manufacturing change control program.
• Designs and delivers training to appropriate personnel as required to enhance OmniaBio’s right to operate and delivery to patients.
• Designs, creates, implements and maintains the customer complaints program.
• Designs, creates, implements and maintains the product recall program.
• As a key member of the Quality Assurance (QA) team, owns and delivers the management review of the quality program and provides status updates to senior management on the overall health of the compliance program.
• Designs, creates, implements and maintains the product documentation and training programs.
• Designs, creates, implements and maintains the audit program (internal audits, client audits and health authority inspections).
• Collaborates with IT business partners to implement the computer validation program.
• Designs, creates, implements and maintains the data integrity program.
• Manages the quality compliance team.
• Hosts health authority and client audits.
• Reviews and approves deviations, CAPA, change controls, and other quality-related documents as required.
• Ensures GMP is embedded in all manufacturing-related tasks.
• Maintains current understanding of GMPs and evolving regulations, and owns OmniaBio’s compliance standards.
• Engages and supports the OmniaBio Operating Model continuous improvement philosophy.

Requirements:

• Bachelor of science degree in science or engineering.
• 10-20 years of equivalent industry experience.
• Must have knowledge of compliance aspects of cell and gene production, sterile manufacture and overall GMP knowledge.
• 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.

Desired Characteristics:

• Capable of managing multiple projects.
• Strong presentation skills and English written and oral communication skills.
• Experienced in driving results by influencing others in a highly cross-functional environment.
• Demonstrates a collaborative and enabling management style.