Master of Science in Quality Assurance and Regulatory Science

Offered in Partnership with the Department of Chemistry, Judd A. and Marjorie Weinberg College of Arts and Sciences, Northwestern University

Science and technology are moving at an increasingly rapid pace, with pressure on industry to get new products to market swiftly while assuring consumers and regulatory agencies that these products are effective and safe. The food, pharmaceutical, and biotechnology industries are challenged to develop processes and procedures to ensure that products meet quality and regulatory standards. Thus, today's laboratory scientist must possess the knowledge, expertise, and skills to create and implement efficient and effective quality systems as well as understand the regulatory and compliance environment. Other essential skills include project management, risk assessment, and risk management. Efficient risk management requires developing quality standards, using the best scientific data, and employing practices that result in clear and consistent decisions and clear communications with the public and regulatory agencies. In the MQARS program Northwestern University has created an industry-standard graduate program in quality and regulatory issues to serve an audience of practicing scientists in the pharmaceutical, food, and biotechnology industries.

The program's 11-course curriculum is designed to bridge the gap between traditional academic programming in the life sciences and the quality assurance and regulatory demands of industry. Scientists holding undergraduate and graduate degrees in fields such as biology, chemistry, bioengineering, biotechnology, and chemical engineering routinely find themselves asked to play a leadership role in quality assurance, yet they are unlikely to have any formal education in this area or possess current knowledge in this increasingly complex field. Pharmaceutical, food, medical device, and other similarly regulated industries face many overlapping quality challenges that are better addressed by a professional master's degree than by internal training programs.

A five-course graduate certificate is available for quality assurance and regulatory affairs professionals seeking only specific course work.

Please be sure to review the important dates pertaining to this program.

Program Outcomes

The objectives of the MQARS program are to:

• provide life scientists in FDA-regulated industries the tools they need to be leaders in quality assurance and regulatory affairs
• increase safety and efficiency in crucial industries in areas such as pharmaceuticals, food, and biomedical
• enhance the skill-set of industry scientists in order to make them more valuable and flexible and improve their career options
• contribute to the professionalization of quality and regulatory areas
• prepare students to transition from the academic to professional demands on life scientists

Career Opportunities

"As more companies continue to mature and shift their focus from R&D to product and manufacturing, the demand for individuals with industry-specific technical, management and team-based problem-solving skills has outpaced the supply of candidates."

-E. Dale Sevier, et al, Nature Biotechnology (Nov. 2003)

Graduates with a master's degree in quality assurance and regulatory science will have an edge when seeking careers in life science and FDA-regulated industries. In recent years, the FDA has become increasingly diligent in enforcement of current Good Manufacturing Practices (cGMP) and other areas of regulation. No company manufacturing products for the food, drug, or medical device industry can afford to do without highly knowledgeable and skilled quality systems experts. Those with a scientific background will augment their value to the industry-and broaden the areas where they can be employed-with this credential.

A Professional Degree

The MQARS is a professional degree that explores foundational knowledge and skills in quality and regulatory areas. In this way, Northwestern University has crafted a program that develops quality and regulatory experts who can operate outside of the narrow silos of specific industries or companies. Industry professionals—at any stage in their careers—will benefit from a curriculum that is both theoretical and applied. The classroom experience complements the knowledge base gained on the job and creates a valuable learning network. The two-part leadership series brings professionals from several industries together and connects the core of the discipline to best management practices.

In order to accommodate the busy schedules of working professionals, the MQARS program is ideal for part-time study. Courses are offered at convenient locations during evening hours over a 10-week quarter. Applications are accepted four times a year, so students can start and complete the program while continuing to meet their professional and private demands.

Features of the Program

• 11-unit program that can be completed in two years
• convenient part-time schedule
• cross-industry curriculum, including best management and statistical practices
• useful to professionals at various stages in their careers
• Northwestern University and industry experts as faculty
• full master of science degree or certificate (Professional Graduate Series) available

For more information about the growing field of quality assurance and regulatory science, visit these sites:

• Regulatory Affairs Professionals Society
• American Society for Quality
• International Association for Food Protection
• The U.S. Food and Drug Administration