Manager, Quality Systems; QMS

Overview

From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act with conviction, and have the courage to work at the edge of the unknown. We offer the opportunity to stretch and explore, and to work on things that matter.

• Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
• Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
• Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
• Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
• Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
• Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
• Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
• Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
• Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
• Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

• You have 5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
• You have a Bachelor’s degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
• You have strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
• You have a solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
• You have experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
• You are proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

AbCellera’s hiring range for this role is CAD $94,880 - $118,600 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, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find we…