Join Sitero as a Senior Quality Assurance Associate, blending hybrid work in Mississauga with essential GCP compliance and TMF management expertise. Ensure adherence to regulatory standards while supporting quality in clinical trials.

This full time role focuses on quality assurance compliance across multiple therapeutic areas. Ideal candidates will have 2-4 years of experience in clinical research QA or TMF management, utilizing their understanding of ICH-GCP guidelines to maintain quality during studies. You will also assist in preparing teams for inspections and promote compliance awareness.

Key Responsibilities:
• Perform regular quality checks on the Trial Master File (eTMF)
• Review site-level essential documents for compliance




• Conduct internal quality reviews adhering to ICH-GCP
• Identify documentation errors and implement CAPAs
• Assist in preparing for regulatory inspections

Requirements:
• Bachelor’s degree in life sciences or a related field
• 2-4 years of clinical research QA experience
• Deep understanding of ICH-GCP guidelines
• Exceptional attention to detail and problem-solving skills
• Strong communication skills for compliance findings

Drive quality assurance and compliance initiatives at Sitero, contributing to innovative clinical solutions.
#J-18808-Ljbffr

📌 Hybrid Senior Quality Assurance Associate (Ontario)
🏢 Sitero
📍 Ontario