Senior Manager, Quality Assurance - Remote

Overview

The Senior Manager, Quality Assurance oversees the activities of the Quality Assurance function and reporting staff to ensure that clinical research activities conform to regulatory requirements and industry best practices.

In Short

• Oversee daily workflow and schedules of the QA department.
• Provide coaching and supervision to QA team members.
• Serve as the GCP lead for quality guidance and support.
• Manage databases for quality systems and prepare quarterly reports.
• Create and track internal audit programs for compliance.
• Collaborate with departments to address quality issues.
• Develop and implement quality assurance policies and procedures.
• Stay updated on regulatory requirements and industry best practices.
• Directly manage 5-7 QA staff members.
• Work in a remote environment with up to 25% travel required.

Requirements

• Bachelor’s Degree or equivalent research experience.
• 8+ years of experience in clinical research.
• 5+ years in quality assurance within a site management or CRO environment.
• Experience performing various quality audits.
• Familiarity with regulatory inspections (e.g., FDA, EMA).
• Strong organizational and communication skills.
• Ability to work independently and manage multiple priorities.
• Customer/client centric service mentality.
• Strong computer skills, especially with clinical trials databases.
• Direct line management experience is an asset.

Benefits

• Work in a supportive and collaborative environment.
• Opportunity to revolutionize access to clinical trials.
• Engage in meaningful work that benefits patients.
• Professional development opportunities.
• Flexible work arrangements in a remote setting.