Quality Associate/Specialist, Technology Quality Management - Remote

Overview

The Quality Associate/Specialist in Technology Quality Management supports compliance with processes and standards related to technology solution development and ensures quality management in clinical research.

In Short

• Define, adopt, and oversee compliance to technology development processes.
• Monitor and implement continuous process improvement.
• Ensure adherence to quality expectations and validation standards.
• Support assessments on low/medium regulatory risk systems.
• Review and approve technology change requests.
• Provide guidance on QMS documents and regulatory requirements.
• Assist project teams with clinical study and validation activities.
• Support audits and corrective action plans.
• Engage in risk assessment for technology used in trials.
• Require analytical and communication skills for quality management.

Requirements

• Undergraduate degree with 1-3 years or College Diploma with 4-6 years of experience.
• Entry/mid-level experience in quality and compliance in clinical research.
• Analytical, critical thinking, and problem-solving skills.
• Knowledge of ICH GCP and global regulations.
• Basic knowledge of continuous improvement methodologies.
• Excellent interpersonal and communication skills.

Benefits

• Opportunity to work in a dynamic field of clinical research.
• Professional development and training opportunities.
• Collaborative team environment.
• Contribution to impactful technology solutions.