Manufacturing Quality Assurance Manager

Reports to: Vice President, Quality Assurance & Regulatory Compliance

Department: Quality

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.

Position Summary:

As Manager, Manufacturing Quality Assurance at OmniaBio, you will be responsible for designing, implementing and managing a manufacturing quality program within a cell and gene therapy manufacturing facility. You will provide quality oversight for the manufacturing operations and the supporting components such as facility and equipment readiness. The person in this role will liaise closely with the Manager, Sterility Assurance, Manager, Compliance and Manager, Outsourced Activity You will be a key member of the Quality management team.

Responsibilities:

Maintains a high level of expertise in manufacturing quality to support, assess and release functions for OmniaBio and its clients.

Designs, creates, implements and maintains the master batch record program.

Designs, creates, implements and maintains the manufacturing deviation program at OmniaBio including a robust root cause analysis system, trending and reporting.

Designs and delivers training to Quality, Manufacturing and Facilities personnel as required to enhance OmniaBio’s right to operate and deliver to patients.

Designs, creates, implements and maintains the batch release process.

Designs, creates, implements and maintains the equipment and room-readiness program.

Collaborates on the management review of quality, identifies trends and provides mitigation as required, as a key member of the Quality Assurance (QA) team.

Manages the manufacturing Quality team, including shift support for ongoing operations.

Develops manufacturing quality assurance standard operating procedures, focusing on evolving regulatory requirements and phase-appropriate GMP requirements.

Provides quality oversight in the management of equipment logbooks/records and preventative maintenance schedule for applicable equipment through collaboration with the Facility management team.

Reviews and approves deviations and out of trend occurrences for the Production team and liaises with other departments for timely resolution of these events.

Collaborates with the Manager, Sterility Assurance on the aseptic gowning qualification program and maintenance of personnel qualifications.

Delivers quality-related services including product release, as contracted to various cell and viral product-centered clients as and when required.

Manages manufacturing QA aspects for quality systems and the validation master plan, equipment qualification, computer systems, cleaning, analytical test methods and process.

Represents Manufacturing Quality as subject matter expert during client audits and health authority inspections.

Supports validation by collaborating, reviewing, and approving master qualification protocols, executed protocols and summary reports.

Reviews and approves deviations, corrective and preventative action, 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.

Requirements:

Bachelor of science degree in science or engineering.

8-10 years of equivalent industrial experience.

Must have knowledge of cell and gene production methods.

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.

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.

Collaborative and encouraging 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.