What does a quality assurance director do?
The job of a quality assurance (QA) director is to oversee all QA functions across the company. Your duties typically include working closely with other department heads to deliver high-quality products on time, hiring managers and analysts, and establishing and maintaining a quality system to make sure that company guidelines and regulatory standards are met. Additionally, you will be responsible for ensuring quality by monitoring, appraising job results, and planning. You are also expected to maintain technical and professional knowledge by reviewing professional publications, participating in professional associations, and attending workshops.
Quality assurance director responsibilities
Here are examples of responsibilities from real quality assurance director resumes:
- Manage the USDA inspection process including coordinating daily production and communicating with federal personnel.
- Manage initial USDA regulatory visits, working collaboratively with USDA inspectors leading audit preparation and follow-up activities and reports.
- Direct and coordinate quality and regulatory affairs activities to support new product development, improving GMP compliance.
- Provide GxP support and oversight for all Genocea development programs.
- Set and execute vision for QRM consistent with corporate objectives and ICH Q9.
- Develop and update metrics within the QMS to provide meaningful feedback to stakeholders.
- Conduct production part review and approval process (PPAP) for new products and modify assembly tools.
- Direct ISO and governmental regulatory inspections.
- Company liaison to ISO registrar and internal/external auditors.
- Re-developed assessment activities associate with CMO performance to ensure proactive compliance.
- Establish product metrics and performance criteria for release over release verification.
- Key contributor to ISO 9/14/18K for safety/environmental impact assessment and implementation.
- Provide analytical expertise and support for completion of CMC sections for regulatory filings.
- Assist in developing and validating instrumental analysis methods for HPLC and UV spectrophotometer.
- Develop and implement test plans which provide end-to-end, regression and new product functionality coverage.
Quality assurance director skills and personality traits
We calculated that 8% of Quality Assurance Directors are proficient in Continuous Improvement, Quality Standards, and Oversight. They’re also known for soft skills such as Interpersonal skills, Leadership skills, and Problem-solving skills.
We break down the percentage of Quality Assurance Directors that have these skills listed on their resume here:
- Continuous Improvement, 8%
Managed data analysis and reporting, identified trends, and drove quality performance goals through continuous improvement initiatives and defect prevention.
- Quality Standards, 7%
Provide timely and accurate quality information to the appropriate departments and personnel in order to achieve desired quality standards of products.
- Oversight, 5%
Reviewed all regulatory and oversight audits conducted by external parties and assured that all deficiencies and/or recommendations are addressed and implemented.
- Test Automation, 5%
Designed and implemented test automation framework and performance tests integrated with NBIC's policy writing application to provide end-to-end test scenarios.
- Scrum, 4%
Process improvement methods to migrate development from a waterfall-based development process to Agile / Scrum method of development process.
- FDA, 4%
Obtained product approvals and maintained product compliance and labeling authority to U.S. FDA and international standards for electrical and mechanical safety.
Most quality assurance directors use their skills in "continuous improvement," "quality standards," and "oversight" to do their jobs. You can find more detail on essential quality assurance director responsibilities here:
Interpersonal skills. The most essential soft skill for a quality assurance director to carry out their responsibilities is interpersonal skills. This skill is important for the role because "industrial production managers must have excellent communication skills to work well other managers and with staff." Additionally, a quality assurance director resume shows how their duties depend on interpersonal skills: "have a good understanding of sdlc best practices and strong interpersonal, written and verbal communication skills. "
Leadership skills. Another soft skill that's essential for fulfilling quality assurance director duties is leadership skills. The role rewards competence in this skill because "to keep the production process running smoothly, industrial production managers must motivate and direct employees." According to a quality assurance director resume, here's how quality assurance directors can utilize leadership skills in their job responsibilities: "provide leadership in all areas of quality assurance/control, fda inspections, iso 13485:2003 and other ww regulatory requirements. "
Problem-solving skills. Another skill that relates to the job responsibilities of quality assurance directors is problem-solving skills. This skill is critical to many everyday quality assurance director duties, as "production managers must identify and address problems that arise." This example from a resume shows how this skill is used: "involved in one fda-gmp audit and resolved issues raised on fda 483"
The three companies that hire the most quality assurance directors are:
- Citi31 quality assurance directors jobs
- BDO USA16 quality assurance directors jobs
- Thermo Fisher Scientific12 quality assurance directors jobs
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Compare different quality assurance directors
Quality assurance director vs. Laboratory manager
Laboratory managers provide accurate laboratory diagnosis through evaluating specimen procedures and coordinating with pathologists to validate laboratory findings. They are responsible for maintaining laboratory tools and equipment, ensuring the proper sterilization of instruments before and after use, organizing equipment based on its function, and immediately repairing or replacing defective items. A laboratory manager also secures the confidentiality of laboratory systems, keeping records of results, and releasing information to the appropriate personnel. Laboratory managers must have a broad knowledge of the scientific industry, as well as excellent analytical and critical-thinking skills.
There are some key differences in the responsibilities of each position. For example, quality assurance director responsibilities require skills like "continuous improvement," "oversight," "test automation," and "scrum." Meanwhile a typical laboratory manager has skills in areas such as "lab equipment," "customer service," "chemistry," and "clinical laboratory." This difference in skills reveals the differences in what each career does.
Laboratory managers tend to make the most money working in the pharmaceutical industry, where they earn an average salary of $90,911. In contrast, quality assurance directors make the biggest average salary, $161,774, in the professional industry.The education levels that laboratory managers earn slightly differ from quality assurance directors. In particular, laboratory managers are 5.4% less likely to graduate with a Master's Degree than a quality assurance director. Additionally, they're 0.6% more likely to earn a Doctoral Degree.Quality assurance director vs. Vice-president of quality
A vice president of quality is responsible for monitoring the quality performance and delivery of the company outputs and deliverables to serve customers and clients. Vice presidents of quality analyze the production and operational processes to ensure that everything adheres to the internal guidelines and regulations. They also coordinate with the stakeholders for project updates and identify opportunities for revenue resources to increase the company's profits. A vice president of quality must have excellent communication and leadership skills, especially in minimizing loss from operational failures and increasing productivity results.
In addition to the difference in salary, there are some other key differences worth noting. For example, quality assurance director responsibilities are more likely to require skills like "test automation," "scrum," "patients," and "liaising." Meanwhile, a vice-president of quality has duties that require skills in areas such as "patient safety," "performance improvement," "quality improvement," and "qa." These differences highlight just how different the day-to-day in each role looks.
Vice-president of qualities may earn a lower salary than quality assurance directors, but vice-president of qualities earn the most pay in the finance industry with an average salary of $122,006. On the other hand, quality assurance directors receive higher pay in the professional industry, where they earn an average salary of $161,774.vice-president of qualities earn similar levels of education than quality assurance directors in general. They're 4.0% more likely to graduate with a Master's Degree and 0.6% more likely to earn a Doctoral Degree.Quality assurance director vs. Manager, quality engineer
A quality engineer manager is in charge of designing and developing quality control procedures, ensuring all products and operations meet the company's standards. Their responsibilities revolve around performing research and analysis to identify business needs, assessing existing quality control methods to identify areas needing improvements, and providing solutions on issues and concerns. Furthermore, as a manager, it is essential to lead and encourage the workforce to reach goals, all while implementing the company's policies and regulations.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a quality assurance director is likely to be skilled in "oversight," "test automation," "scrum," and "patients," while a typical manager, quality engineer is skilled in "quality engineering," "lean six sigma," "qa," and "aerospace."
Managers, quality engineer earn the best pay in the technology industry, where they command an average salary of $124,149. Quality assurance directors earn the highest pay from the professional industry, with an average salary of $161,774.Most managers, quality engineer achieve a similar degree level compared to quality assurance directors. For example, they're 2.4% less likely to graduate with a Master's Degree, and 1.7% less likely to earn a Doctoral Degree.Quality assurance director vs. Director of quality
In the manufacturing industry, a director of quality is primarily in charge of spearheading and overseeing the daily operations in a quality assurance department. They work to ensure that products adhere to the company's quality standards and industry regulations by conducting research and assessments, developing quality test systems, and reviewing reports. As a director of quality, they have the authority to make significant decisions, establish protocols and guidelines, set objectives and timelines, and implement rules and policies, creating new ones as necessary.
Types of quality assurance director
Updated January 8, 2025
