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Qa operations manager

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AbCellera Biologics

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Location:
Canada , Vancouver

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

105000.00 - 120000.00 CAD / Year
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Job Description:

We are looking for a QA Operations Manager to serve as a trusted Quality partner on the cleanroom floor, providing real-time GMP oversight for our Drug Substance manufacturing operations. In this role, you will lead the development and implementation of quality systems and procedures, drive end-to-end management of quality events including deviations, CAPAs, and change controls, and play a key role in supporting clinical batch disposition. You will partner closely with cross-functional teams across Manufacturing, Supply Chain, Quality Control and Facilities & Engineering to ensure inspection readiness and regulatory compliance as we advance our antibody therapy pipeline. This is a unique opportunity to help shape quality operations at a pivotal stage of AbCellera's growth.

Job Responsibility:

  • Developing and implementing quality systems and oversight programs for Drug Substance (DS) GMP manufacturing, including product changeovers, batch record review, and shop floor surveillance
  • Partnering with CMC teams as the embedded QA representative, contributing quality expertise and guidance to ensure regulatory and quality requirements are seamlessly integrated across CMC projects
  • Completing review and approval of GMP documentation - such as batch records, SOPs, logbooks, risk assessments - ensuring full GMP and regulatory alignment and in support of clinical batch disposition
  • Maintaining inspection readiness of the facility and identifying and escalating risks to members of the site leadership team
  • Supporting inspections and audits of the clinical manufacturing facility
  • Participating in end-to-end quality event management, including deviations, investigations, CAPAs, and change controls, collaborating cross-functionally to drive root cause analysis and on-time record closure
  • Contributing to manufacturing risk assessments, from identification and evaluation through to mitigation, documentation, and reporting
  • Managing material qualification reviews to support procurement and GMP compliant use of raw materials and components
  • Acting as a key quality partner across Manufacturing, QC, Supply Chain, F&E, and project management teams, ensuring seamless quality oversight of DS programs
  • Staying ahead of evolving Quality and Regulatory requirements, proactively assessing their impact on AbCellera and driving timely mitigation strategies to maintain compliance
  • Supporting broader Quality Assurance activities, as required by program deliverables, such as QA for QC, QA for materials management, and opportunities identified by the Quality team

Requirements:

  • Bachelor's or Master's degree in a relevant scientific discipline
  • 8+ years of GxP industry experience
  • at least 5 years in a quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment
  • strong command of current pharmaceutical regulations and guidances including FDA, Health Canada, EU, and ICH
  • hands-on experience with biological Drug Substance and aseptic manufacturing processes, including associated testing requirements
  • comfortable navigating systems such as ERP (SAP), eQMS, and LIMS
  • communicate with clarity and confidence
  • self-starter who takes ownership, drives results, and thrives with autonomy in a fast-moving, mission-driven environment
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 is a priority

Additional Information:

Job Posted:
May 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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