Program Overview

An interdisciplinary professional program, the MQARS curriculum emphasizes applied science, leadership, and communication skills. Students explore concepts and problems in quality assurance and regulatory affairs that span life science industries, thus encouraging a cross-pollination of best practices and systems.

Students who complete the MQARS program gain the skills and knowledge to:

• understand the current regulatory environment for applied life sciences within a global context
• understand the nature of quality assurance within regulated industries
• assess and develop quality and regulatory strategies for specific industries, including pharmaceuticals, biotechnology, and food
• develop and utilize project management skills to conduct research and clinical trials as demanded by regulatory agencies
• understand and apply principles of risk management and ethical enterprise compliance
• create quality assurance processes that support compliance auditing requirements
• represent persuasively the role of quality assurance in spurring innovation throughout an enterprise

Scientists already working in quality assurance and regulatory affairs areas, as well as those moving into this subfield, should be able to assume managerial functions after completing this degree.

Curriculum

An interdisciplinary professional program, the MQARS curriculum emphasizes applied science, leadership, and communication skills. Students explore concepts and problems in quality assurance and regulatory affairs that span life science industries, thus encouraging a cross-pollination of best practices and systems. The MQARS curriculum focuses on these interdisciplinary core competencies and foundations while also stressing practical applications. Students complete seven core courses, two electives, one capstone project, and a leadership course designed to integrate managerial skills into the course of study.

Core Courses (7 courses)

• QARS 401 Regulation and Quality Systems
• QARS 405 Applied Research and Writing
• QARS 410 Introduction to Statistical Methods for Regulatory Compliance
• QARS 420 Practical Laboratory Management
• QARS 421 Applied Quality and Regulatory Practices
• QARS 430 Ethical and Legal Issues in Regulation and Quality
• QARS 435 Risk and Decision Management

Electives (choose 2 courses)

• QARS 415 Advanced Statistical Methods for Regulatory Compliance
• QARS 425 Quality Assurance Project Management
• QARS 440 Food Quality Assurance
• QARS 450 Medical Device Regulations
• QARS 460 Drug and Biologics Regulations
• QARS 490 Special Topics in Regulatory Affairs

Leadership Class (1 course)

SCS strives to equip its students with fundamental skills in effective leadership, communication, innovation, and change management. To gain exposure to theories and best practices in these administrative areas, MQARS students join other SCS graduate students in a 10-week leadership class. With these skills complementing the core curriculum, graduates are better prepared to face the challenges of the modern workplace.

Capstone Project (1 course)

The final course in the MQARS program is an independent research project in which students integrate the knowledge they have gained in the curriculum with a topic of relevance to their professional goals. Working with MQARS faculty, students conduct research while also contributing something of practical value to the field. The capstone project counts as one unit of credit, and students have up to one year to present their final research.