Associate Director, Quality Assurance, GMP

Role Overview

• Contribute to the management of Xenon’s quality systems and activities
• Compile and evaluate quality metrics and trends
• Manage batch release operations activities
• Lead and manage critical activities and milestones
• Facilitate and resolve quality issues with CDMOs
• Maintain CDMO site readiness for regulatory inspections
• Apply risk-based review processes for GMP documentation
• Contribute to training initiatives and GMP compliance interpretation
• Participate in on-site regulatory inspections and audits
• Establish and maintain effective working relationships
• Act in accordance with Company policies
• Some domestic and/or international travel may be required

Requirements

• Bachelor’s degree in life sciences
• approx. 8+ years of management and Quality Assurance experience
• Strong knowledge and experience with global GMP regulations
• Good understanding of the drug development process
• Previous experience with drug substance or drug product manufacturing
• Strong critical thinking and decision-making skills
• Organizational skills and attention to detail
• Proficient in conducting quality audits
• Ability to work autonomously and collaboratively
• Clear, concise, and professional written and oral communication skills
• Experience maintaining an electronic quality management system is beneficial.

Benefits

• base salary
• target bonus
• stock options
• medical insurance
• dental insurance
• vision insurance
• short-term disability
• long-term disability
• accidental death & dismemberment insurance
• life insurance programs
• Employee Assistance Program
• travel insurance
• retirement savings program with company matching contributions
• vacation
• personal days
• sick days
• end-of-year company shutdown
• employee development
• expanding Training, Learning & Development program
• Tuition Assistance program for advanced degrees