What Is the Role of the Director of Quality Assurance and Quality Control in Pharmaceuticals?

Directors of quality assurance and quality control working for pharmaceutical companies oversee lower-level quality assurance managers and inspectors within drug manufacturing plants. Pharmaceutical quality assurance directors must ensure that the drug manufacturing process complies with government regulations and stringent manufacturing standards so that drugs are safe and work as promised.

Pharmaceutical Quality Assurance

Quality assurance work in the pharmaceutical industry grew out of the federal Pure Food and Drug Act of 1906, which required that medication manufacturers put truthful ingredients labels on drugs that contained alcohol, opium or morphine. A quality assurance director today deals with a huge array of issues, ranging from possible drug contamination caused by slack equipment cleaning habits to a plant’s failure to pass federal inspection because of poor record keeping. The director’s primary responsibilities fall into two categories — quality control and compliance with national and international regulations.

Quality Control Responsibilities

Quality assurance directors in the pharmaceutical industry hire and supervise quality assurance managers and quality control inspectors. A director oversees investigations into incidents where manufacturing practices fail to comply with required standards and alerts other company executives to these incidents and the resulting follow up investigations. The quality assurance director manages all aspects of a plant’s quality control systems, including documentation of quality control, and monitoring the activities of material suppliers from outside of the company. A director may educate executives in other departments about quality control processes. Finally, the director prepares the budget for the quality assurance department.

Regulatory Compliance Duties

A quality assurance director for a pharmaceutical company holds primary responsibility for seeing that the drug manufacturing process follows the U.S. Food and Drug Administration’s (FDA’s) regulations and any applicable international regulations. The FDA requires that pharmaceutical companies register all drug manufacturing plants; submit lists of drugs, their ingredients and their labels; inspect drug samples, packaging and labels; and sample and test drug materials and drug products during the manufacturing process. The quality assurance director must oversee these activities and document them for the FDA . A director must also educate the plant’s quality assurance employees and other key personnel about relevant federal and international regulations and alert them to changes in these regulations.

Career Outlook

Quality assurance directors in the pharmaceutical industry generally possess a bachelor’s, master’s or doctoral degree in pharmaceutical sciences, biochemistry or another science related field and at least 10 years of experience in the pharmaceutical industry. They earn an average salary between $120,000 and $130,000 per year. The U.S. Department of Labor’s ONet Online database classifies pharmaceutical quality assurance directors as part of a larger category of “quality assurance managers” in all industries. In 2012, the ONet Online database forecast a decline of 3 percent in all quality assurance manager jobs in all industries between 2012 and 2022. The pharmaceutical industry as a whole is losing jobs due to slower rates of new drug approvals by the FDA, expiration of many older drug patents, and outsourcing of research and drug clinical trials to foreign countries.