Our client is currently seeking an Associate Director of GCP QA to join their growing quality team. This is a hybrid position supporting a well-funded clinical stage Biotech client in the Greater Boston area.

Day to day you will:

• Support GCP/GLP studies from a QA perspective(primarily GCP)
• Conduct GCP & GLP audits(primarily GCP)
• Support development of Quality Management Systems
• Ensure safety & PV programs are mature and compliant
• Assist in navigating vendor management issues

You should apply if you have:

• 8 years of GCP/GLP QA experience
• Experience with preparing for approval audits
• Experience developing QMS
• Strong vendor management experience
• Experience supporting GCP/GLP audits