Clinical Quality Assurance Director

Job Summary

A company is looking for an Associate Director, Clinical Quality Assurance.

Key Responsibilities

• Develop partnerships with clinical study teams to identify quality risk exposure in ongoing clinical studies
• Ensure compliance with clinical quality assurance activities, including managing GCP audits
• Support regulatory inspections and maintain a quality-focused culture across the organization

Required Qualifications

• BA/BS degree required; advanced degree preferred
• Minimum of 8 years of experience in the bio-pharmaceutical R&D industry, with at least 6 years in GCP Quality Assurance
• Experience in drafting and optimizing standard operating procedures (SOPs)
• Knowledge of global regulations and guidance for GCP, GVP, and CSV/A
• Working knowledge of Veeva or similar QMS e-systems required