Manager, External Quality

2 weeks ago

Ontario, Canada OmniaBio Inc Full time

Reports to: Vice President, Quality Assurance & Regulatory 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.

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.

Responsibilities:

  • 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.

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.

Desired Characteristics:

  • Capable of managing multiple projects.
  • Strong presentation skills with 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.

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