ResponsibilitiesSupporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirementsSupporting 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 requirementsContributing 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 complianceSupporting the Business Process Owner (BPO) for QC laboratory systems (e.G. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycleOverseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objectsDeveloping, 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 sessionsProviding QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessmentsSupporting qualification and computer system validation activities for QC systems (e.G., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructureCollaborating 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 processesQualificationsYou have 3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidanceYou have a Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciencesYou have strong understanding and hands‑on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environmentsYou 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 solutionsYou 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 controlYou are proactive in identifying opportunities for improvement, with solid critical thinking and problem‑solving skillsWhat We OfferAbCellera’s hiring range for this role is CAD $76,000 – $95,000 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, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.#J-18808-Ljbffr

📌 Specialist, Qc Systems - C$76,000 - C$95,000 A Year (Toronto)
🏢 AbCellera
📍 Toronto