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(Senior) Manager, Quality Risk Management (CMC/GMP)

AbCellera Biologics

AbCellera Biologics

Quality Assurance
Vancouver, BC, Canada
Posted on Tuesday, December 6, 2022

AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 400 AbCellerites and growing, we’re expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.

The (Senior) Manager, Quality Risk Management will be responsible to establish and apply quality risk management activities in all aspects of our operations including development, manufacturing, distribution and the lifecycle process of our products. The activities include the assessment, control, communication and review of quality risks to our products in close compliance with ICH Q9 requirements. The role will also allow for a strong cross-functional collaborative approach with internal and external partners to drive risk-based decisions to meet product quality and regulatory expectations. Freedom will be given to create and design appropriate risk assessment tools and supporting processes and procedures.

We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!

We’d love to hear from you if

  • You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
  • You have a proven track record of integrating quality risk management processes into industry and regulatory operations
  • You are passionate about working with dynamic new teams and capabilities that accomplish ambitious goals
  • You are an outstanding communicator with external partners and a teammate

How you might spend your days

  • Establishing, implementing and maintaining an efficiently integrated and robust quality risk management program in compliance with ICH Q9.
  • Creating and implementing AbCellera’s quality risk management tools, standards and procedures for all relevant aspects of our organization
  • Mapping and executing QRM plans and reports for CMC/ GMP activities
  • Facilitating/guiding risk management for CMC/GMP activities, including formulation of an appropriate risk question, managing external resources, and training and mentoring team members on QRM
  • Coordinating risk management activities and overseeing the QRM system to enable timely identification and communication of quality and compliance risks, and appropriate mitigation and risk reduction actions
  • Leading periodic reviews of QRM efforts to foster continual process improvement initiatives and assist in making improved, proactive decisions
  • Designing and reporting quality risk metrics, risk review results and risk mitigation actions
  • Continuously driving improvements to the established QRM and QMS and related processes, increasing speed and efficiency while meeting regulatory and business requirements
  • Monitoring and ensuring current and new QRM regulations, guidelines and industry trends are appropriately implemented into the Quality Management System (QMS).
  • Providing ongoing collaboration, engagement, and education to cross-functional teams for sustainability, compliance and effectiveness of the QRM system
  • Interfacing with quality, regulatory, and leaders to establish clear and consistent requirements and risk management activities related to intended use, user, environment, and product performance over a broad and complex portfolio of molecules

Required qualifications and experience

  • Bachelors or Masters degree or higher in (bio)-chemistry, biotechnology, pharmacy, or other relevant discipline
  • 8+ years of working experience in the quality organization within the biotechnology, pharmaceuticals, or life sciences industry
  • Proven hands-on experience with quality risk management methodologies including FMEA, FTA, HACCP, PHA, etc. for medicinal and/or combination products; experience with risk management for medical devices is a plus
  • Strong computer skills with Quality Systems (e.g. QRM e-system, eDMS, eQMS).
  • A thorough understanding of the drug development and manufacturing processes, with an ability to understand business requirements and translate them into practical solutions
  • Excellent communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management
  • Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team

About AbCellera

At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.

We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. 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. We’re looking for someone like you to support and organize our efforts along the way.