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    Specialist, Quality Management System - Vancouver, Canada - AbCellera

    AbCellera
    AbCellera Vancouver, Canada

    2 weeks ago

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    Description

    AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed.

    The Quality Management Systems(QMS) Specialist will be responsible for the overall design, implementation and management of our QMS for all AbCellera operations, including our state-of-the-art clinical manufacturing activities. In this role, based in Vancouver, Canada, you will bring your expert experience in the design of key quality processes and drive the implementation and continual improvement of our electronic QMS (eQMS).

    How you might spend your days

  • Establishing, designing, implementing, maintaining, and monitoring QMS framework processes (CAPA, change, deviation, risk, audit and complaint management) in close collaboration with the CMC/GMP team
  • Creating and maintaining QMS policies, standard operating procedures, and related documentation for the QMS activities
  • Designing and leading AbCellera's Quality Risk Management program following ICHQ9
  • Continuously improving the QMS in a phase appropriate manner to gain agility, simplicity, efficiency, while preserving high quality standards and meeting contemporary global CMC/GMP requirements and expectations. This includes the implementation and improvement of an eQMS system
  • Overseeing the performance and effectiveness of QMS programs, as well as supporting quality risk management, audit management, complaint management, and data integrity
  • Supporting Health Authority inspections, partner audits and supporting drafting of follow-up responses for all aspects of the business
  • Collaborating with training teams to provide insight and guidance on the planning and implementation of quality system training to ensure a closed loop within all QMS activities
  • Providing cross functional quality leadership and acting as a CMC/GMP compliance subject matter expert
  • Implementing department goals, utilizing critical thinking, and applying problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle

    • We'd love to hear from you if

  • You have a bachelor's or master's degree in a relevant scientific discipline and 5+ years of Quality industry experience within biotechnology, the pharmaceutical industry, or life sciences
  • You have 5+ years of quality system management experience in a GxP regulated environment
  • You have hands-on experience in Quality Risk Management as defined in ICHQ9
  • You have a strong understanding and experience in the application of electronic quality management systems and continuous process improvement principles, including global GxP requirements and other relevant regulations and guidance (ICHQ10) to assure quality products, patient safety and data integrity
  • You have experience in GMP manufacturing for biologics, including aseptic technique and operations, environmental monitoring programs, and media simulation studies
  • You have a thorough understanding of drug development processes from discovery through CMC development, with an ability to understand business requirements and translate them into practical quality systems solutions
  • You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
  • You are an outstanding communicator and teammate and you lead by example

    • What we offer

    AbCellera's hiring range for this role is CAD $80,000 - $100,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

    You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you'll find we prioritize teams and social groups to build community and connections across AbCellera.

    About AbCellera

    AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

    And it all starts with our team. We've built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.

    We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.

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