Canada, Calgary
Fulltime: 40 hrs a week
Experience: 6-9 Years
Education Level: Academic Bachelor
Pharmaceuticals
Closing: September 16, 2025

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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

Why 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 Us

Brunel 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.

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