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Director – QA Validation
Confirmed live in the last 24 hours
Vancouver, BC, Canada
Experience Level
Desired Skills
Quality Assurance (QA)
  • Bachelor's or Master's degree in a relevant scientific or engineering discipline and 12+ years of industry experience within pharmaceuticals, biotechnology or life sciences
  • 6+ years of Quality (QA) Validation leadership experience in a GxP regulated environment such as pharmaceuticals, biotechnology or equivalent
  • Recognized expert in the field of validation, and solid understanding of biologics Drug Substance (DS) and Drug Product (DP) process equipment, QC lab equipment, facility equipment such as autoclaves and WFI systems, and disposable manufacturing technologies
  • Extensive GMP Validation experience including Validation Master Plans, process, utility, and facility IQ/OQ/PQ, QC lab equipment validation, process validation (including PPQs and CPV), cleaning validation, hold time studies, and mixing studies
  • Excellent knowledge of global Health Authority (Health Canada, US FDA, EMA, HPRA, etc.) cGMP regulations (incl. US FDA 21 CFR Part 11), guidelines and relevant industry standards
  • Experience in IND/BLA regulatory section authoring and establishing audit/inspection readiness
  • Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments
  • Experience in managing and mentoring a quality team
  • Demonstrated productive interactions with regulatory agencies and health authorities
  • Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team
  • Excellent documentation and organizational skills
  • Superb verbal and written communication skills, including public presentation of complex data
  • You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
  • You are passionate about building dynamic new teams and capabilities that accomplish important goals
  • You have a bias towards innovation over industry standards
  • You are an outstanding communicator and teammate
  • You demonstrate excellent problem-solving skills
AbCellera Biologics
Company Overview
AbCellera Biologics is a biotechnology company that develops antibody therapeutics to improve patient outcomes.