Quality Assurance Manager

Introduction

We 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 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.

Responsibilities

• Maintain 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.

Requirements

• 5–10 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 Offer

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About Us

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