QA Operations Manager

AbCellera•Vancouver, BC

9d•$105,000 - $120,000•Onsite

About The Position

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.

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, and understand how they apply in practice
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
Ability to hit the ground running in a tech-enabled manufacturing environment
Communicate with clarity and confidence, equally effective presenting to both technical and non-technical stakeholders
Self-starter who takes ownership, drives results, and thrives with autonomy in a fast-moving, mission-driven environment

Responsibilities

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