Pharmaceutical Quality Director – A Day in the Life

Medical care is often associated with a visit to a physician or nurse, but pharmaceutical companies play an equally important role in dispensing live-saving medications to patients.

The pharmaceutical industry is a major player in the U.S. economy and is beholden to key stakeholders: patients, board members, and medical researchers. According to the Mayo Clinic, nearly 70 percent of Americans take one prescription drug and more than half of all Americans take two prescription drugs (Mayo Clinic). Data from Pew Charitable Trust projects that $584 billion U.S. dollars will be spent on pharmaceutical drugs in the year 2020 (Pew Charitable Trust 2019). Pharmaceutical companies also bring in 23 percent of the healthcare revenue in the United States and makeup 63 percent of the total profits (Fortune 2019).

Consumers and corporations need to know that the drugs dispensed by pharmaceutical companies are manufactured safely and efficiently. Pharmaceutical quality directors ensure that quality control protocols are followed within the industry’s manufacturing, testing, and inspection procedures.

To safeguard the manufacturing of pharmaceuticals, a specific blend of scientific and business knowledge is required. Pharmaceutical quality directors typically have bachelor’s degrees in science or business. Many pursue master’s degrees in health administration (MHA) in order to develop areas of professional specialization and earn higher salaries. MHA programs offer prospective pharmaceutical quality directors the opportunity to sharpen their skills in communication and finance and specialize in best business practices that relate to pharmaceuticals.

Companies hiring for these positions generally look for candidates with five to ten years of managerial experience in the science, chemistry, or pharmaceutical industries. Whether supervising teams in charge of drug development or the manufacturing of medications, pharmaceutical quality directors provide essential oversight for patient safety and corporate efficiency.

Read on to learn more about a day in the life of a pharmaceutical quality assurance director.

Pharmaceutical quality directors work in a variety of settings ranging from office environments to sterile product manufacturing sites. Some positions require work in aseptic laboratories, which entails following specific safety protocols and wearing goggles, gloves, and respiratory protection to prevent the transmission of bacteria and viruses. Other work requirements include visits to supplier sites, travel to industry-related conferences and events, and off-site meetings with vendors.

By virtue of being in a position of leadership, pharmaceutical quality directors oversee and interact with teams of people. In management roles, pharmaceutical quality directors provide guidance to quality assurance staff by setting group objectives and ensuring that all projects and initiatives align with the company’s missions and goals. In tandem with finance professionals, pharmaceutical quality directors prepare annual budgets, annual plans, and make quarterly financial predictions. Together with members of upper management, pharmaceutical quality directors establish strategic organization plans and objectives. With quality control being a primary responsibility, pharmaceutical directors must interact with and report to specialists in risk management, and operations and regulatory standards.

Pharmaceutical quality assurance directors are responsible for a variety of tasks and teams, which means that a typical schedule will widely differ depending on current projects. Generally, their professional tasks can be divided into two categories: internal and external. The internal tasks are generally more focused on management within the company while the external tasks deal primarily in compliance and collaboration outside of the company.

Below is a list of typical responsibilities of a pharmaceutical quality director:

• Review and approve standard operating procedures for technical, fiscal, and scientific accuracy
• Approve conformance certifications for drug manufacturing
• Oversee employee training which aligns with regulatory and industry standards
• Provide analysis and support for problem-solving
• Manage manufacturing, operations, and regulatory teams within a company
• Evaluate information to confirm that products comply with U.S. Food & Drug Administration (FDA) regulations
• Measure the purity, safety, and potency of manufactured drugs
• Manage quality assurance staff and ensure that safety practices are understood and followed
• Prepare annual budgets and quarterly projects
• Work with individuals and teams to improve operations efficiency
• Suggest improvements in operations and risk management in manufacturing or laboratory settings
• Participate in corporate strategic planning
• Maintain safety standards set by state, federal, and international regulatory organizations
• Participate in professional development through industry associations

While responsibilities vary for every position, a pharmaceutical quality director’s daily tasks are driven by determining the answer to the question: what can be improved? Professionals in these positions are largely responsible for determining the cause and the source of inefficiency, analyzing how to solve the problems caused by inefficiency, as well as taking action to solve these problems and get processes and projects back into motion.

Combining scientific and managerial skills, pharmaceutical quality directors must use a specific mixture of technical professional skills in order to do their jobs well.

For those aspiring to become pharmaceutical quality directors, an undergraduate degree in a field of science or business administration is the first step. Students majoring in chemistry, biology, or closely-related laboratory science are well-equipped to handle the scientific responsibilities of these positions, as are students with academic backgrounds and experience in business administration.

To learn more specialized skills, many future pharmaceutical quality directors pursue master’s degrees in healthcare administration. Students often have the option to specialize in specific areas of study related to risk management and may also have access to internships and other professional development opportunities to prepare them for work in future administrative roles.

Some companies require pharmaceutical quality directors to have previous experience in management in the pharmaceutical or a closely-related industry. Gaining professional management experience through internships or work experience is recommended for those seeking leadership positions in pharmaceutical quality assurance.

In addition to education, technical skills, and scientific knowledge, pharmaceutical quality directors must have strong communication skills. Being in charge of managing and interacting with teams tasked with manufacturing and distributing safe and suitable pharmaceuticals is a heavy responsibility; there is little to no room for mistakes in written and verbal communication. Clarity and collaboration are necessary to ensure patient safety and that the research and development of new pharmaceuticals to serve the medical needs of patients continues.

Professional certification and licensure requirements vary by state and company. While certification and licenses may not be required for all positions, having these credentials can provide an added benefit of helping a candidate stand out when applying for or changing jobs within the pharmaceutical industry.

Certification is available as a pre- and post- master’s degree option through universities and professional industry standards organizations. Below are two certifying organizations for pharmaceutical quality directors:

• American Society for Quality (ASQ)
• Pharmaceutical Education and Research Institute (PERI)