Senior Director of Quality Assurance

4 weeks ago


Vancouver, British Columbia, Canada AbCellera Full time
About the Role

AbCellera is seeking a highly skilled and experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Provide exceptional leadership to the Quality Assurance team, including hiring, mentoring, and developing staff.
  • Build and establish a quality management system that meets regulatory requirements and industry best practices.
  • Develop and implement quality risk management, knowledge management, and document management systems.
  • Collaborate with cross-functional teams to ensure timely and compliant progression of projects.
  • Author and review regulatory documents, including INDs, BLAs, and other relevant dossier sections.
  • Ensure compliance with Health Canada, FDA, EMA, and local regulations, as well as ICH guidelines and AbCellera policies.
Requirements
  • Bachelor's degree or equivalent, with 15+ years of experience in the biopharmaceutical or device industry.
  • 12+ years of experience in a quality organization, with previous experience in manufacturing or quality assurance.
  • 6+ years of experience building, leading, developing, coaching, and mentoring a cross-functional team.
  • Experience implementing phase-appropriate quality systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines, and industry best practices.
  • Strong quality mindset and ability to influence across the entire organization.
What We Offer

AbCellera offers a competitive salary range of $190,000 - $235,000, annually, commensurate with education and job-related knowledge, skills, and experience. We also offer equity, annual bonus, and comprehensive health benefits.

At AbCellera, we prioritize work-life synergy and offer a $1,500 annual active lifestyle allowance, professional development opportunities, and abundant team and social groups to build community and connections.



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