RCI-GT-38899 Lead Investigator

2 weeks ago

Mississauga, Ontario, Canada Rangam Full time

Lead Investigator – Complaints & Quality

Role Summary

The Lead Investigator is responsible for leading product complaint investigations and trend analysis for company products, including
Devices, Combination Products, and Drug Delivery Systems
, with a primary focus on the
Port Delivery System (PDS)
. This role supports both
clinical trial
and
commercial
products and ensures timely investigation, root cause analysis, and resolution of quality issues to maintain product and process control.

Key Responsibilities

Complaint Investigation & Quality Oversight

  • Lead and manage
    product complaint investigations
    (critical and non-critical) with minimal supervision.
  • Ensure investigations, action plans, and final reports meet
    GMP, regulatory, and company quality standards
    .
  • Initiate, review, approve, and close records in the
    Quality Management System
    (Complaints, Deviations, CAPAs, etc.).
  • Perform and lead
    root cause analysis
    , present findings, and recommend actions to Quality Review Boards (QRB).
  • Monitor complaints, identify trends, and escalate issues requiring immediate attention.

Cross-Functional Collaboration

  • Work closely with Manufacturing, Packaging, Device Quality, Affiliates, and Supply Chain teams to drive timely investigations.
  • Act as the
    Quality representative
    on cross-functional and multi-site teams.
  • Communicate with patients and healthcare professionals when required.

Quality Improvement & Compliance

  • Identify process gaps and lead improvement initiatives within complaint handling and quality systems.
  • Support audits, inspections, recalls, and regulatory reporting activities.
  • Develop and maintain quality metrics, trend reports, and risk assessments.
  • Write, review, and approve
    CAPAs
    to ensure effective resolution of quality issues.

Leadership & Mentorship

  • Provide training and guidance on complaint processes and quality procedures.
  • Mentor team members and promote a culture of
    quality, compliance, and continuous improvement
    .

Education & Experience

  • Bachelor's degree or higher (Life Sciences preferred).
  • 8+ years
    of experience in pharmaceutical, biopharmaceutical, or medical device quality.
  • Strong experience with
    complaint handling, investigations, CAPAs, and trend analysis
    .
  • Knowledge of
    drug, device, combination products, and drug delivery systems
    .
  • Experience with
    GMP, Quality Systems, and global regulatory requirements
    .
  • Familiarity with Six Sigma / DMAIC and quality problem-solving tools.
  • Experience working in a
    global, cross-functional environment
    .

Skills & Competencies

  • Strong understanding of
    GMP, Quality Systems, and Health Authority regulations
    .
  • Excellent analytical, problem-solving, and critical-thinking skills.
  • Strong written and verbal communication skills (English required).
  • Ability to influence and collaborate across teams without formal authority.
  • Organized, proactive, and able to manage complex investigations independently.
  • Continuous improvement mindset (Lean / Agile).
  • Additional language skills are a plus.

Travel

  • Minimal travel required (up to
    5%
    ).

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