Clinical Quality Compliance Manager

Job Summary

To ensure compliance and quality in clinical trials, the remote Clinical Quality Compliance Manager will manage the Quality Management System (QMS), oversee quality operations, and lead a high-performing quality team while maintaining regulatory standards.

Key responsibilities

• Implement and maintain quality systems aligned with regulatory requirements and foster a culture of quality excellence
• Manage core QMS processes, including document control, training management, and audits, while operationalizing the electronic Quality Management System (eQMS)
• Provide quality oversight across clinical study development and collaborate with cross-functional teams to ensure Good Clinical Practice (GCP) compliance

Required qualifications

• BA or BS in a related field
• 8+ years of progressive experience in Quality, including 2+ years leading quality teams
• Deep knowledge of regulatory frameworks such as GCP, ISO 9001, and 21 CFR Part 11
• Hands-on experience with eQMS in a fast-growth or startup environment
• Experience in regulated healthcare, life sciences, or digital health companies