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Change Control Lead – Quality Operations

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Amaris Consulting

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Location:
Canada , Toronto

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Category:
-

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Contract Type:
Not provided

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Salary:

50000.00 - 110000.00 CAD / Year
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Job Description:

We are seeking an experienced Change Control Lead – Quality Operations to support a regulated manufacturing site in Toronto. This is a highly visible, on-site role focused on leading change control activities end to end, partnering with cross-functional teams, and ensuring compliant, timely, and high-quality execution within a GMP environment.

Job Responsibility:

  • Own and drive the full change control lifecycle from initiation to closure, including scope definition, impact and risk assessments, action planning, implementation oversight, effectiveness checks, and closure
  • Ensure appropriate routing and approvals across Quality, Engineering, Manufacturing, Supply Chain, IT, Validation, and other relevant functions
  • Author, review, and improve high-quality change records with clear rationale, justification, and traceability
  • Triage and prioritize incoming change requests
  • support stakeholders in defining implementable and compliant changes
  • Maintain trackers, manage backlogs, escalate risks or delays, and propose recovery plans
  • Facilitate and document quality risk assessments (e.g., FMEA or equivalent)
  • Ensure alignment with GMP, data integrity expectations, and site quality standards
  • Link change controls to deviations and CAPAs when applicable and ensure timeline alignment
  • Coordinate validation and qualification impact assessments (IQ, OQ, PQ, CSV, requalification)
  • Lead cross-functional working sessions and provide concise weekly status reporting
  • Identify recurring issues and propose continuous improvement initiatives to simplify and strengthen change control processes

Requirements:

  • 5–7 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment
  • Strong hands-on experience executing change controls within a Quality Management System
  • Solid knowledge of GMP and audit-ready documentation practices
  • Proven ability to lead cross-functional discussions and drive actions to closure
  • Leadership experience or strong leadership capability
  • Ability to work on-site in Toronto most days, preferably daily at the beginning

Nice to have:

  • Experience with deviations, CAPAs, investigations, and root cause analysis
  • Validation exposure (CSV and/or Commissioning & Qualification)
  • Experience in sterile manufacturing, biologics, vaccines, or high-containment environments
  • Familiarity with quality metrics, trackers, dashboards, and right-first-time documentation approaches
What we offer:
  • An international community bringing together more than 110 different nationalities
  • An environment where trust is central: 70% of our leaders started their careers at the entry level
  • A strong training system with our internal Academy and more than 250 modules available
  • A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Additional Information:

Job Posted:
January 15, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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