Director, QA Compliance

Director, GCP QA Compliance (Remote)

Our client is a clinical stage biotech that is seeking a Director of Quality Compliance to lead GCP quality systems and ensure compliance with US, EU, and global regulations. This role will oversee quality processes including policies, SOPs, deviations, change control, CAPAs, document control, training, and vendor audits. Responsibilities include building and managing the quality management system, supporting clinical and future commercial activities, leading system implementations, and ensuring inspection readiness.
 

Requirements:

• Bachelor’s or Master’s in a scientific field with progressive experience in biotech/pharma clinical quality
• Strong knowledge of GCP QA regulatory requirements and quality systems
• Experience developing and managing quality processes
• Risk management, root cause analysis, and inspection support experience
• Excellent communication, project management, and organizational skills
• Up to 20% travel