If you’re considering a career in regulatory affairs, quality assurance (QA) offers both leadership opportunities and career longevity. The director of quality assurance is one of the top jobs in this growing field and is a vital member of the leadership team in industries including pharmaceuticals, medical devices, food, and nutritional products. Quality assurance has come a long way since its roots in ammunition testing during World War II. Today, quality assurance teams minimize the possibility of errors and inconsistencies in a wide range of products before their market release.
Within the regulatory discipline, the line between regulatory affairs and quality assurance is clearly defined, with both playing critical roles in keeping products safe. Regulatory affairs teams ensure that products comply with relevant government regulations and legal standards. Their quality assurance partners are responsible for the processes that guarantee the production and delivery of high-quality products—focusing on preventing issues through consistent and proactive production standards. The QA team is led by the director of quality assurance who typically reports to the vice president of regulatory affairs and quality assurance.
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Cross-Functional Collaboration Gets the Job Done
A quality assurance director makes sure high-quality products are delivered on time and within budget. The role oversees all the systems, processes, and initiatives that alleviate quality issues. Directors work with internal partners whose responsibilities relate to compliance and production. “As a director of quality assurance, you work as a cross-functional collaborator with all the divisions in your company,” says Leona Saunders, PhD, lecturer in Northeastern University’s Master of Science in Regulatory Affairs (MSRA) program. “You’re also a project manager, focused on multiple paths leading in and out of production, all of which impact the company’s bottom line,” Saunders adds.
Saunders sees the role and the field evolving along with changing regulatory requirements and regulations. “If you’re looking to move up the career ladder in quality assurance, you’ve got to be flexible, detail-focused, and have strong project management skills,” she says. “As internal and external circumstances change, you have to be able to see things in different ways and be constantly improving procedures.”
Director of QA Job Description
To advance within quality assurance and potentially move into the top position, candidates need to have the required skills—gained through a combination of work experience and education. You’ll need to be prepared to succeed at the following typical job components:
- Maintain product quality by creating, monitoring, and enforcing quality standards that align with both company procedures and government requirements
- Oversee procedures for testing methods, materials, and products
- Create quality documentation systems and update as procedures evolve
- Prepare quality reports that analyze and evaluate essential information
- Be an expert on product and consumer requirements—to establish quality and reliability standards
- Ensure products meet customer expectations and promised specifications without variation
- Understand the work, needs, and challenges of partners in management, production teams, technicians, and engineers
- Collaborate with other members of management to develop new product/engineering designs, including manufacturing and training methods
- Recruit and train employees
- Attend industry workshops/seminars and stay up-to-date with professional publications
- Prepare budgets, schedule expenditures, and monitor variances
The Skills Needed to Succeed as QA Director
Education and practical experience can provide the required job skills—but many are personal traits. If you have interests and abilities in the sciences, chances are you are a good candidate for a quality assurance career. Saunders says, “There are several personal skills that help people succeed in quality assurance. If I’m hiring someone, I’d want to know if they’re detail-focused and have good communication, relationship, and leadership skills. Whether it’s regulatory, compliance, or quality, you’ll be working across functions. Good candidates can negotiate with and influence people without being bossy.” Other skills that Saunders highlights include analytical, problem-solving, project planning, and writing skills—primarily technical.
An Advanced Degree Opens Doors
The educational background of many people working within quality assurance and regulatory affairs is in the life sciences—but some enter the field with an engineering, business, or liberal arts undergraduate degree. Whether they enter the industry with a master or doctoral degree or earn one later to further their career, 64 percent of regulatory professionals hold an advanced degree.
Saunders has an interesting vantage point to discuss the range of opportunities gained by procuring an advanced degree. In addition to being a lecturer in Northeastern’s regulatory affairs program, she launched her regulatory career by earning her master of science in the same program. She speaks as a former student as well as an educator. Saunders says, “If you’re working in quality assurance, you’ve got to understand the process of making products. QA jobs have many elements, though, so companies are very aware of building their organizations with a broad foundation. Northeastern’s regulatory affairs advanced degree is a great way to set yourself up for a successful career in quality assurance or regulatory affairs.”
The Northeastern MSRA program features a dedicated quality assurance and compliance concentration. Students study the application of standards and regulations to the development and commercialization of healthcare or food products. Saunders says, “When I did the program, it was general and only had ten courses. It has been exciting to participate in the expansion. There’s a depth of course offerings that enhance the skills of any regulatory professional.”
Saunders sees the regulatory field looking for candidates that are subject matter experts. She says, “It’s impossible to learn everything. I encourage all my students to pick the area of regulatory affairs that interests them and focus their degree towards that. You don’t want to graduate as a generalist. You will branch out to new skills when you’re in the field. I started in pharmaceutical development, but over the last 20 years, I’ve had my hands in areas from preclinical studies to postmarketing commitments. In regulatory affairs, compliance, and quality assurance, you’ll be continually learning.”
Moving Up the Ranks in Quality Assurance
Like many fields, to move into a leadership position, you need to move up the ranks by excelling in your current role to be promoted to the next level. Saunders advises students to just get in the door in a related position and then prove their talents and broaden their skills. When you’re on the job, take advantage of the educational opportunities provided by your employer. Build your contacts through industry events and associations. The Society of Quality Assurance offers student memberships that include many benefits, including publications, learning opportunities, and job listings.
For those that choose to take the next step, whether it’s planning your education, changing careers, or exploring ways to power your path within quality assurance—you can be confident that opportunities within regulatory affairs will continue to grow.
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