Manager, Quality Systems (QMS) Job at AbCellera Biologics (Vancouver)

Job Description

As the Manager, Quality Systems, you will support the design, implementation, and ongoing management of the data architecture and eSystems required to support QC-related CMC/GMP activities. Your role will play a critical part in ensuring the effective implementation, execution and continuous improvement of the QC-related eSystems within AbCellera, while maintaining compliance with applicable global regulations and regulatory expectations. You will provide functional ownership and oversight of QC laboratory electronic systems (eSystems), ensuring they are fit-for-purpose, compliant, and enable efficient, data-driven laboratory operations. Working cross-functionally, you will help foster a strong culture of quality across the CMC/GMP organization. You will be empowered with a high degree of ownership and autonomy to innovate, move quickly, and build scalable quality and digital capabilities that leave a lasting impact on our organization and industry.

Job Responsibility

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

Requirements

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
Bachelor’s degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
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
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections

AbCellera Biologics - All Job Offers

Select Country

Manager, Quality Systems (QMS)

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Manager, Quality Systems (QMS)

Quality Systems Manager

Senior QA Manager, Quality Systems

Quality Systems Manager

Quality Systems Manager

Quality Systems & Laboratory Manager

Quality Management Systems Manager

Quality Systems Pmo Program Manager

Qa Sr Manager External Supply Quality (Esq) - Supplier Quality Management

Our AI answers in your language