Lead QA Operations Manager

Position: Lead QA Operations Manager at AbCellera
Join AbCellera as the Lead QA Operations Manager to oversee quality assurance in Vancouver’s biological Drug Substance manufacturing. Your expertise will help maintain rigorous compliance.

In this dynamic role, you’ll play a critical part in improving QA operations with over 12 years of GxP industry experience. Your hands-on leadership will guide the Quality team and ensure best practices while managing compliance with regulations set by governing bodies like FDA and Health Canada.

Key Responsibilities:

• Own Quality oversight for GMP manufacturing and distribution

• Ensure compliance through effective batch reviews and material release

• Guide root cause investigations to enhance quality processes

• Partner with teams on tech transfers and regulatory submissions

• Maintain inspection readiness and manage audit programs

Requirements:

• At least 12 years of GxP experience, including leadership roles

• Deep understanding of pharmaceutical industry regulations

• Proven skills in team leadership and talent development

• Familiarity with aseptic manufacturing processes

• Clear communicator across all levels of stakeholders

Protect and elevate product quality with your leadership skills in QA Operations at AbCellera.