Senior Manager/Associate Director, QA Operations

AbCellera•Vancouver, BC

1d•CA$124,000 - CA$155,000•Onsite

About The Position

We're looking for an experienced Associate Director/Senior Manager, QA Operations to lead Quality oversight for our biological Drug Substance clinical manufacturing facility (Brightfield) in Vancouver. You'll provide real-time Quality support to cGMP manufacturing, warehousing, and distribution operations, ensuring activities meet regulatory expectations and industry best practices — all while driving continuous improvement and building a strong culture of quality across the site. If you are someone with deep technical expertise in Quality and hands-on GMP leadership experience, who can partner effectively across Manufacturing, Supply Chain, and Regulatory teams to keep operations running smoothly and compliantly, we’d love to hear from you.

Requirements

12 years of GxP industry experience, including at least 5 years in a Quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment, in addition to a Bachelor’s or Master’s degree
A strong command of current pharmaceutical regulations and guidances, including FDA, Health Canada, EU, and ICH, and know how to apply them in practice
Known for building and leading high-performing Quality teams and coaching direct reports to help build their technical capabilities, while holding the bar high on accountability
Hands-on experience with biological Drug Substance and aseptic manufacturing processes, including the testing requirements that go along with them
Navigating systems such as ERP (SAP), eQMS, and LIMS with ease, and can hit the ground running in a tech-enabled manufacturing environment
Communicating with clarity and confidence, equally effective with technical experts and non-technical stakeholders alike
A self-starter who takes ownership, drives results, and thrives on autonomy in a fast-moving, mission-driven environment

Responsibilities

Owning Quality oversight across GMP manufacturing, warehousing, and distribution, ensuring compliant, uninterrupted operations from clinical stage through future commercial supply
Driving batch record review and material disposition, enabling timely release of GMP materials to keep clinical programs moving without delay
Leading root cause investigations, CAPAs, and change controls, using structured problem-solving tools to eliminate recurring issues and strengthen GMP operations
Providing Quality partnership for tech transfers and new product introductions, including review of technical documents supporting regulatory agency submissions
Overseeing material qualification and phase-appropriate release of raw materials and components
Championing continuous improvement initiatives that elevate quality performance, compliance, and operational excellence site-wide
Shaping Quality policies and procedures, playing a key role in internal and external audit programs, and translating evolving regulations into practical site systems
Maintaining inspection readiness and serving as a key partner during health authority inspections, proactively identifying and escalating risks to site leadership
Leading risk-based evaluation, mitigation, and reporting initiatives to safeguard product quality and regulatory compliance
Building and coaching a high-performing QA Operations team, managing resourcing and quality metrics/KPIs, and partnering closely with Site Operations, MSAT, Product Development, Quality Control, and Warehouse/Logistics teams to ensure seamless quality oversight of Brightfield's Drug Substance manufacturing programs