Associate Director of Quality Assurance

Job Summary

To provide strategic oversight in clinical development, the remote Associate Director of Quality Assurance will manage compliance with GCP requirements, drive process improvements, and lead issue management across multiple studies.

Key Responsibilities

• Represent QA in operational process improvement initiatives, ensuring alignment with regulatory expectations and risk-based quality management principles
• Establish mechanisms to measure process adoption and compliance, leading post-implementation oversight activities to ensure operational execution aligns with updated procedures
• Lead the management and documentation of Quality Events across studies, driving root cause analysis and establishing standardized approaches for issue resolution

Required Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degree preferred
• Minimum of 8 years of experience in GCP Quality Assurance or related roles within the pharmaceutical, biotech, or CRO environment
• Strong experience in GCP regulations, inspection readiness, and quality systems
• Demonstrated experience in process improvement and operational excellence initiatives
• Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements