OmniaBio: Manager, External Quality

4 weeks ago

Canada OmniaBio Inc Full time

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 & Regulatory Compliance

Department: Quality

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 Inc. 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.

OmniaBio Inc. 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.

OmniaBio Inc. 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. #J-18808-Ljbffr

  • Quality Assurance Manager

    6 days ago

    Canada Imploy Full time

    Position Summary: The Quality Assurance Manager is responsible for ensuring that all products and services produced by the company comply with the highest standards of quality, safety, and reliability. This includes developing and implementing a comprehensive quality assurance system to monitor performance, identify and resolve problems, and ensure that...

  • Manager, External Affairs

    38 minutes ago

    Canada Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Manager, External Affairs

    7 days ago

    Canada Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Manager, External Affairs

    1 week ago

    Canada Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Manager, External Affairs

    1 week ago

    Canada, CA Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Manager, External Affairs

    1 week ago

    Canada Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Manager, External Affairs

    1 week ago

    Canada Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Manager, External Affairs

    1 week ago

    Canada Fintechs Canada Full time

    In a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...

  • Project Manager, Quality Management

    4 weeks ago

    Canada Engage ESM, an Eviden Business Full time

    CAD citizen, PR We are a team of professionals who care about the quality of our work and are globally recognized by best-in-class CSAT. You will be responsible for leading Canadian and global projects and/or programs, primarily for Fortune 500 companies. Strong foundational knowledge of ServiceNow: with ability to explain business implications of...

  • Director, Site Quality

    3 weeks ago

    Canada ICON Strategic Solutions Full time

    Perform study management tasks as per agreed delegation/oversight by SrGSL/GSL In partnership with internal experts and external service providers, provide oversight (as delegated by the SrGSL/GSL) to ensure study delivery of both internally-run and outsourced studies.. Maintain and facilitate interactions with both internal & external functions to...

  • Project Manager, Quality Management

    2 weeks ago

    Canada BrickRed Systems Full time

    We are seeking a skilled and experienced Project Manager with a strong background in Title insurance, project management, Agile methodologies, and technical expertise in Azure DevOps / TFS, .Net, and related technologies. The ideal candidate will have a minimum of 3 years of project management experience, with a proven track record of successfully delivering...

  • Quality and Regulatory Coordinator

    25 minutes ago

    Canada Baby Gourmet Foods Full time

    Baby Gourmet is a Canadian company specializing in organic baby and toddler food. We emphasize clean, healthy, and naturally nourishing food for children, ensuring parents can trust the quality and nutritional content of their products. The company highlights its commitment to minimizing exposure to industrial and environmental contaminants and boasts...

  • Assistant Director

    3 weeks ago

    Canada Housing Quality Network Full time

    Bursting with culture, energy, and opportunity, the London Borough of Waltham Forest is a fantastic and exciting place to work. We are a highly ambitious borough. Driven by culture and the innate creativity of our residents, we have developed new and innovative ways to build our communities. Our Council is relentlessly resident-focused, insight-led,...

  • Quality and Regulatory Coordinator

    4 days ago

    Canada Baby Gourmet Foods Full time

    Baby Gourmet is a Canadian company specializing in organic baby and toddler food. We emphasize clean, healthy, and naturally nourishing food for children, ensuring parents can trust the quality and nutritional content of their products. The company highlights its commitment to minimizing exposure to industrial and environmental contaminants and boasts...

  • Clinical Research Quality Manager

    2 days ago

    Greater Toronto Area, Canada, Ontario Trial Management Group Inc. Full time

    TMG is a national clinical research Site Management Organization (SMO) that has pioneered the representation of private practice physicians in the conduct of clinical research trials. Since 1995 TMG has been training physician investigators and study coordinators in proper research conduct and facilitating their participation in phase II – IV...

  • Program Manager, Quality

    2 days ago

    Canada Amazon Full time

    在庫管理・品質保証（ICQA）チームでは、日々拡大と進化を続けるアマゾンの物流拠点であるフルフィルメントセンター（以下FC）において、オペレーション品質および在庫品質の更なる改善を推進するプログラムマネージャーを募集しています。...

  • Quality Manager Job In CANADA

    4 days ago

    Canada CLOUD VISA IMMIGRATION LLP Full time

    Apply for Quality Manager Job In CANADA, CLOUD VISA IMMIGRATION LLP in Canada for 3 - 8 Year of Experience on

  • Quality Manager Job In CANADA

    4 days ago

    Canada CLOUD VISA IMMIGRATION LLP Full time

    Apply for Quality Manager Job In CANADA, CLOUD VISA IMMIGRATION LLP in Canada for 3 - 8 Year of Experience on TimesJobs.com.

  • Senior Manager, Data Quality Management

    3 weeks ago

    Canada CIMA Canada Inc Full time

    At CIMA+, you’ll find a place where you’ll have many opportunities to learn and develop while working on engaging projects. You will have the flexibility to manage your work on your own terms and define what work-life balance means to you. Are you enthusiastic about continuously improving the employee and customer experience? Do you have the desire...

  • Quality Management Automation Lead

    3 weeks ago

    Canada Marketers on Demand Full time

    You are a highly-motivated and accomplished individual in the analytics & decision solutions space and will be responsible for setting and leading various projects & strategies. Responsible for the high-quality delivery of ADS projects; provide strong domain expertise in data science and decision optimization •Coach and develop your team with your ADS...