Director, Quality Assurane

About the role

This position will be responsible to lead and oversee the site wide quality management program designed to ensure continuous measurement and improvement in site compliance and performance. This includes building a high-performing and highly effective QA team, implementing key global initiatives at the site level, and ensuring the integrity and consistency of site operations and client deliverables. The position will employ effective tools to support risk assessment and mitigation of quality issues and to address and resolve quality events by implementing measures to correct and prevent future occurrences. The position will also be responsible for ensuring compliance to applicable laws, guidelines and regulation governing the site's operations. The success of the role will be measured by, but is not limited to, continuous improvement of site operational quality and compliance, efficiency of operational workflows, meeting or exceeding client expectation and corporate goals and objectives.

Responsibilities

• Oversee the Quality Management System and work closely with all site departments and functions
• Manage a high-performing and effective site quality team
• Promote processes that ensure data integrity, consistency, continuous improvement and compliance with quality and business requirements
• Ensure study workflows produce high quality data and deliverables to meet and exceed client expectations
• Prepare, host, and respond to findings for external client audits and regulatory inspections
• Prepare non conformance reports and monitor reporting performance and trends
• Oversee CAPAs, including investigations, root cause analysis and implementation of corrective procedures and preventive actions to ensure timely resolution of issues
• Perform internal quality and EHS audits according to site and global SOPs
• Perform