Introduction

We are currently hiring a seasoned hands-on QA leader who can shape quality culture while executing operational quality activities 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 clinical trials across North America and globally.

What are you going to do

  • Maintain and continuously improve the Quality Management System (QMS)
  • Develop and implement an annual Quality Plan and perform internal quality audits
  • Conduct external vendor qualifications and investigative site audits
  • Deliver GCP and regulatory training to internal teams and external partners
  • Lead or support regulatory inspections and sponsor audits, including readiness, hosting, and follow-up
  • Manage the CAPA lifecycle and analyze trends in quality findings
  • Review SOP deviations, ensure audit follow-through, and maintain compliance documentation
  • Collaborate closely with Clinical Operations, QA Specialists, and IT to uphold quality across functional teams
  • Track and report quality performance metrics and KPIs to leadership
  • Promote a proactive quality culture while addressing ongoing operational needs

Essential skills and knowledge 

  • 5-10 years of experience in clinical research, with a strong GCP QA background
  • Experience with drug and device trials (Phase I-III)
  • Proficient in internal/external auditing and vendor qualification
  • Familiarity with Canadian and U.S. regulatory frameworks (Health Canada Division 5, FDA)
  • Experience with eQMS systems (ZenQMS preferred)
  • Experience in computer systems validation (CSV), data integrity, or IT QA
  • QA certifications (e.g., RQAP-GCP, ASQ CQA) are an asset
  • Confident, organized, and quality-driven
  • Comfortable working autonomously and collaboratively
  • Strong communicator with a strategic and practical mindset
  • Passionate about improving processes and supporting team success
  • Comfortable juggling priorities in a growing, fast-paced environment

What we offer

What We Offer

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Closing: September 16, 2025

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Vacancy reference: PR-257189

QV

Corporate recruiter

Quynh Vo

+1 514 841 4133

Contact

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