Manager, Quality Risk Management (CMC/GMP)
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 Manager, Quality Risk Management (QRM) will establish and maintain an efficiently integrated quality risk management program in compliance with ICH Q9. Including the definition of QRM risk scales, QRM decision trees and the creation of appropriate risk assessment tools used to enable the use of QRM to contribute to better, data-driven, risk-based decisions supporting product quality and meeting regulatory expectations. The role will also facilitate complex cross-functional risk evaluations and support issue resolution by employing a methodical and collaborative approach to risk analysis, whether conducted as part of investigations or as a separate analysis of specific risk questions. Freedom will be given to innovate and move at lightning speed to create a legacy in our industry.
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 are passionate about building dynamic new teams and capabilities that accomplish important goals
- You have a bias towards innovation over industry standards
- You are enthusiastic about applying your expertise in QRM
- You have the ability to identify and define phase-appropriate CMC and GMP risk assessment requirements and to prepare the related plans and reports
- You are an outstanding communicator and teammate
How you might spend your days
- Establishing, supporting and maintaining an efficiently integrated and robust quality risk management program in compliance with ICH Q9 and AbCellera’s policies, standards, procedures and applicable global CMC/GMP requirements
- Creating, and executing QRM plans and reports for CMC and 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
- Driving consistency in standards and practices and facilitating the communication of risks identified in facilities, clean utilities, equipment, personnel, process and related activities
- Coordinating risk management activities and overseeing the QRM system to enable timely identification and communication of 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
- Preparing/reviewing and reporting quality risk metrics, risk review results and risk mitigation actions
- Continuously driving improvements to the established QRM and related processes, increasing speed and efficiency while meeting regulatory requirements
- Monitoring and ensuring current and new QRM regulations, guidelines and industry expectations 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
- A Bachelors or Masters degree in a relevant discipline and 8+ years of industry experience within biotechnology, pharmaceuticals, or life sciences working within quality risk management
- 5+ years of Quality System management experience, preferably in performing, facilitating, and managing risk assessments
- 2+ years experience building, leading and developing teams within quality systems
- Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, PRA, etc.)
- Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. QRM e-system, eDMS, eQMS).
- A thorough understanding of the drug development processes from discovery through CMC development, with an ability to understand business requirements and translate them into practical solutions
- A proven track record in delivering change and transformation projects and their associated benefits to an agreed time-line, budget and quality
- Excellent communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management
- Results oriented, and able to effectively execute on projects with minimal supervision
- Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team
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.
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