A Key to Better Business Decisions

Good internal audit programs and auditing practices enable an organization to evaluate the effectiveness of its Quality Management System, and promote continuous improvement by uncovering opportunities for quality and product improvement. Great internal audit programs and practices do this, and they deliver an additional return on investment to the organization by providing insight into business decisions that influence manufacturing, supplier and contractor selection as well as product innovation. Unfortunately, many internal audit programs fall short of delivering recommendations for continuous improvement, let alone providing insights into better business decision making.

About the Author

Marie McDonald is Senior Director, Quality & Compliance, with Consulting at Quintiles. She has extensive experience in business case development, program and project planning and execution, process improvement design, training, and business transformation.

She has led or facilitated a wide range of projects, including quality systems evaluation, process improvement and technology implementation, as well as regulatory remediation and compliance improvement. She partners with global clients, and spent two years working and living in Ireland.

Throughout Marie’s career she has led project teams that developed and delivered technology enablement for GMP business processes including manufacturing, quality control, and quality assurance. She also created and executed quality system audits for business processes and information technology systems, helping clients confirm compliance with governing SOPs, GMPs, and to ensure data integrity.

Marie holds a BS in Business Administration from Shippensburg University and an MS in Career and Technical Education from Virginia Polytechnic Institute and State University. She serves on the Board of Directors of the Greater Philadelphia Chapter of the Healthcare Businesswomen’s Association (HBA).