Reporting to the Vice President of Quality, our Global Quality Assurance group is managed by a QA leadership team composed of QA leaders in Discovery & Preclinical, Early Clinical Research & Bioanalytical Services, Global Clinical Development and Global Central Labs. The leadership team ensures that standards, processes and personnel are in place to achieve consistent and effective QA performance across all locations within their purview and partners with operational leaders to ensure that QA is aligned with business goals. The QA leadership team members provide subject matter expertise and assistance to all operating locations. They work closely with local QA and Operations personnel to share information, leverage experience and create consistent practices in addition to supporting local activities.
The leadership team is also responsible for the development and ongoing management of the MDS Pharma Services Quality Management System (QMS) to implement the policies and procedures, performance management metrics, and training necessary for implementation of the QMS process. Within the QA leadership team, a Computer Validation group is responsible for compliance with computer validation and Part 11 requirements. This group partners with MDS Inc. Information Technology and MDS Pharma Services’ local operations to ensure that MDS and regulatory agency computer validation/Part 11 standards are met across all locations.