Job Description: The Pharmaceutical Quality Director

How can the health care industry ensure that medications are not only safe, but effective? Pharmaceutical quality directors manage systems that protect millions of Americans who take medications for short- or long-term treatment. Drug companies invest millions in researching, developing, and testing drugs in the hope of treating medical conditions and diseases. Instrumental in that drug development process is quality control.

Quality control requires many gatekeepers to safeguard the public. Patient safety is one of a pharmaceutical quality director’s main responsibilities, but it is only part of the job. For those who are considering different types of health administration or pharmacy careers, it helps to understand the basics of the pharmaceutical quality director job description.

What Are the Prerequisite Requirements for Pharmaceutical Quality Director Positions?

While most individuals applying for work in pharmaceutical quality control hold bachelor’s degrees in the sciences or business, possessing a Master’s in Health Administration (MHA) offers a definitive edge when trying to secure a job. The work completed in an MHA program sharpens strategic management skills key in performing the responsibilities of a pharmaceutical quality director. MHA students also develop the skills in finance and communication needed to tackle the complex demands that pharmaceutical quality directors routinely confront.

Organizations that hire pharmaceutical quality directors often prefer candidates who have five to 10 years of experience working in supervisory or management positions, or a similar amount of experience working in pharmaceuticals, chemistry, or other related sectors. Employers also value candidates with experience in strategic planning, allocating resources, and leading a team. Knowledge of chemical compositions and processes is desirable because pharmaceutical quality directors need to competently manage production of a pharmaceutical product. Clerical and customer service skills are also highly important.

Useful Skills for Pharmaceutical Quality Directors

Critical thinking

Quality control involves testing and inspecting pharmaceutical products. It also requires the evaluation of the manufacturing process itself. Results of those tests and inspections require analysis and interpretation, all of which demand sharp critical thinking skills. The MHA curriculum helps students develop these thinking skills by exposing them to situations where they must determine how to solve relevant issues by evaluating them from different perspectives.

Data and observational analysis

Pharmaceutical quality directors must apply excellent judgment to know when and what appropriate corrective measures to take when problems arise. To guide their decision-making, they collect and analyze data, and then use their findings to make observations about the pharmaceutical testing and inspection processes. Based on their observations, they then provide feedback to the production staff. Earning an MHA degree can help them develop this skill, because the program features coursework that breaks down the methods that today’s health care institutions use to extract actionable information from health care data.

Financial comprehension

Pharmaceutical quality directors play important roles in planning and directing quality assurance operations. Relative costs and benefits are a factor in that process. Therefore, a solid comprehension of finances is important when making decisions about potential actions to take. MHA programs typically cover finance management techniques in-depth to prepare graduates to use those skills in their future careers.

Attention to detail

Quality control is important in any type of manufacturing; however, in the pharmaceutical industry, where people’s health and lives are at stake, quality assurance programs are critical and require especially close attention to detail. Professionals in pharmaceutical quality assurance help prevent mistakes and defects by developing methods to verify that the drugs meet specified requirements. MHA programs teach students to observe complex processes and identify possible risk factors when performing such tasks.

Communication

Pharmaceutical quality directors communicate important quality control information to vendors, contractors, and stakeholders in their own organizations. They also must know how to listen closely to all members of their teams, because they coordinate with and supervise accountants, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators. Taking graduate-level health administration courses allows students to develop communication skills by placing them into situations where communicating with their peers, instructors, and other faculty will help them succeed in their studies.

Pharmaceutical Quality Director Job Description: Duties and Responsibilities

• Pharmaceutical quality directors evaluate information to verify that pharmaceutical products comply with FDA regulations, and they release their findings in reports before the products go to market. The reports must demonstrate how the analytical procedures of the manufacturing process meet established FDA standards.
• Pharmaceutical quality directors measure the quality of products by comparing them to accepted performance indicators, such as identity, safety, purity, and potency.
• Pharmaceutical quality directors create new strategies to limit defects in pharmaceutical products.
• Pharmaceutical quality directors communicate important quality control information to management and other departments of the organization.

Expected Salary and Projected Job Growth

Work in the field is predicted to hold steady, with 11,600 job openings between 2016 and 2026, and median pay for pharmaceutical quality directors is $81,760 a year.

The pharmaceutical quality director job description has many layers and offers dynamic work to interested candidates. For those who are results oriented and value opportunities that challenge them analytically while providing a certain level of independence to work on their own and make decisions, a career in pharmaceutical quality control is worth exploring.

Learn More

Graduates of Regis College’s online Master of Health Administration program are equipped with the skills to become successful leaders in a variety of health professions. Find more details about courses and future career options on Regis’ MHA program website.

Recommended Readings:

Improving Patient Safety

MPH vs. MHA: 5 Key Differences

4 Challenges Facing the Health Care Industry

Sources:

National Center for O*NET Development

World Health Organization: Quality Assurance of Pharmaceuticals

World Health Organization: Essential Medicines and Health Products 

Food and Drug Administration: Analytical Procedures and Methods Validation for Drugs and Biologics