Quality Assurance Manager

IntroductionWe are currently hiring a hands-on Quality Assurance (QA) professional to strengthen the quality culture and ensure operational compliance across internal teams, vendors, and clinical sites.Our client is an established Canadian Clinical Research Organization (CRO) supporting innovative biotech and biopharma clients with early-phase (Phase I–IIIB) clinical trials across North America and globally.This position is ideal for a QA expert who enjoys execution and problem-solving, not just oversight—someone who thrives in a fast-paced, collaborative, and entrepreneurial environment.ResponsibilitiesMaintain and continuously improve the Quality Management System (QMS), ensuring alignment with GCP and ISO principles.Lead the implementation and operationalization of the QMS (e.g., eQMS rollout, R3 integration).Conduct internal quality audits, vendor qualifications, and investigative site audits to ensure GCP compliance.Deliver GCP and regulatory training to internal teams and external partners.Support and host regulatory inspections and sponsor audits, ensuring readiness and timely follow-up.Manage the CAPA lifecycle, trend analysis, and root cause investigations to drive continuous improvement.Review SOP deviations, maintain quality documentation, and ensure effective audit response follow-through.Collaborate closely with Clinical Operations, Regulatory, and IT teams to ensure compliance and operational efficiency.Report on quality metrics and KPIs, escalating critical issues proactively to leadership.Communicate clearly and concisely with internal and external stakeholders, providing practical quality solutions.Requirements5–10 years of experience in clinical QA, with hands-on involvement in audits, inspections, and GCP compliance.Experience with phase (I–IIIB) clinical trials and innovative drug development.Strong working knowledge of Health Canada Division 5, FDA, and ICH-GCP regulations.Proficiency in eQMS platforms (ZenQMS preferred); experience in system implementation or validation (CSV) is an asset.Exceptional written and verbal communication skills – able to simplify regulatory concepts for cross-functional teams.Comfortable executing QA activities day-to-day while contributing to process improvement.QA certifications (e.g., RQAP-GCP, ASQ CQA) considered an asset.Strong attention to detail, accountability, and initiative.What We OfferWhy apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We’ll get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.