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
Please send resume to sarah.viall@meetlifesciences.com if you are interested in learning more.