Senior Director, Quality Assurance

3 weeks ago

Vancouver, British Columbia, Canada AbCellera Full time

AbCellera is a global company dedicated to discovering and developing antibody-based medicines that improve people's lives. We are driven by a team of scientists, engineers, creatives, and business professionals who believe in the power of science to enhance well-being. Our focus lies in unlocking high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer treatment, as well as complex transmembrane proteins for conditions like metabolic disorders, endocrine issues, pain, and autoimmunity.

We are seeking a highly motivated and experienced Quality leader to join our team as the Senior Director, Quality Assurance & Regulatory Strategy. In this role, you will be responsible for building a world-class quality organization and establishing robust systems to ensure we meet our ambitious goal of bringing groundbreaking therapies from discovery to commercialization within an accelerated timeframe.

Your Impact:

  • Provide exceptional leadership to the organization, fostering a culture of excellence through hiring, mentoring, and developing top talent.
  • Establish and lead the QA organization (CMC/GxP), directing, coordinating, and managing all reporting Quality Assurance functions.
  • Develop and implement comprehensive vendor/supplier selection, qualification, and governance processes, as well as internal/external audit programs.
  • Design and implement a robust quality management system encompassing all aspects of our operations, ensuring compliance with regulatory requirements.
  • Lead the development and execution of regulatory strategies for our product portfolio, guiding submissions to ensure timely and successful approvals.
  • Collaborate closely with cross-functional teams, including research & development, manufacturing, and clinical operations, to integrate quality into every stage of the drug development process.

About You:

You are a seasoned professional with a proven track record in leading quality assurance and regulatory affairs within the biopharmaceutical industry. Your deep understanding of GMP, GLP, and GCP regulations, coupled with your strategic thinking and leadership skills, will be instrumental in driving our success.

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