About OmniaBio:
OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput. This innovative approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. OmniaBio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting-edge therapies worldwide. Visit www.omniabio.com to learn more.
Active Vacancy
Position Summary:
As Director, Quality Compliance, at OmniaBio, you will be responsible for 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.
- Oversee and accountable for the corrective and preventive action (CAPA) program.
- Oversee and accountable the manufacturing change control program.
- Oversee and accountable for the training program to enhance OmniaBio’s right to operate and delivery to patients.
- Oversee and accountable for the customer complaints program.
- Accountable for the product recall program.
- As a key member of the Quality 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.
- Oversee and accountable for the documentation program.
- Implements and Accountable for the audit program (internal audits, client audits and health authority inspections).
- Collaborates with IT business partners to implement the computer validation program.
- Oversee and accountable 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.
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.
