Senior Director of Quality Assurance

7 days ago

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

AbCellera is a global biopharmaceutical company that discovers and develops antibody-based medicines. We are seeking a highly experienced Senior Director of Quality Assurance to join our team.

Key Responsibilities
  • Lead the development and implementation of quality systems to support the company's growth and expansion.
  • Build and manage a high-performing quality team, providing guidance and mentorship to ensure the team's success.
  • Develop and maintain quality policies, procedures, and standards to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure the timely and compliant progression of projects.
  • Author and review regulatory documents, including INDs and BLAs.
  • Ensure activities and deliverables are in compliance with Health Canada, FDA, EMA, and local regulations and guidance.
Requirements
  • 15+ years of experience in the biopharmaceutical or device industry, with 12+ years in a quality organization.
  • 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.
  • A strong quality mindset and ability to influence across the entire organization.
  • Self-motivated and able to identify project needs and follow up with building and implementing solutions.
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 within the company.

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