Clinical Quality Compliance Expert

2 days ago


Canada ICON Strategic Solutions Full time
About ICON Strategic Solutions

We are a leading provider of clinical research solutions, committed to delivering high-quality services to our clients. Our team is dedicated to ensuring the integrity and reliability of our operations.

Job Title: Manager, Clinical Quality ComplianceSalary: $120,000 - $150,000 per year

This role will focus on process development, implementation, and quality assurance in compliance with GCP and regulatory requirements.

Responsibilities:
  • Point of contact for quality and compliance questions, working closely with QA to ensure alignment and consistent messaging.
  • Support teams in identifying and mitigating risks, providing training as needed.
  • Prepare teams for regulatory inspections, ensuring adherence to GCP and overall quality standards.
  • Contribute to the facilitation of lessons learned and propose process improvements.
  • Review critical findings from QA audit reports to suggest process enhancements.
  • Develop CAPAs and collaborate with QA for global inspections.
  • Support SOP/WI development, reviewing critical documents.
  • Measure progress and target results from improvement projects.

Requirements:

  • Bachelor's degree
  • 5 years of experience in a pharmaceutical or Contract Research Organization company in a Quality role
  • Understanding of Clinical Operations activities
  • Experience with sponsor/site audits and developing processes/SOPs/WIs
  • Strong written and oral communication skills
  • Prior Regulatory inspection experience desired

About You:

  • Problem-solving and leadership skills
  • Knowledge of relevant procedures
  • Customer Service mindset
  • Team Player/Ability to interact and collaborate with key stakeholders
  • Adaptability and ability to drive solutions
  • Broad knowledge of Clinical Operations


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