For any product that is mass produced, quality management is key. Without it, it could lead to faulty products, costly recalls, and irreversible reputational damage. In Life Sciences, particularly in pharmaceuticals, quality is one of the most important aspects as it directly affects the safety, efficiency, and value of all products. With the product of the pharma industry mainly targeted for human consumption, any lapse in quality management could lead to a negative effect on patient health. This is why the pharmaceutical industry is heavily regulated to prevent such disasters, and why quality management is so important.
Control Vs Assurance
Quality management is the act of overseeing all activities and tasks that must be accomplished to maintain a desired level of excellence. Within the quality management process, there are many different roles that are required to help achieve this level of excellence. Two of the most essential roles are Quality Control (QC) and Quality Assurance (QA). While the titles sound quite similar, the roles themselves are very distinct. Quality Control can be defined as part of quality management, focused on testing and inspections, and fulfilling quality requirements, while Quality Assurance relates to how a process is performed or how a product is made.
In the context of quality management, QA is a continuous process as it involves establishing processes and systems to prevent defects from occurring; QC works in parallel to detect and correct defects that may have occurred despite the QA efforts. The two roles work hand-in-hand, ensuring the overall product is produced safely and within regulatory guidelines. In simpler terms, QA manages the quality; QC verifies it.
Demand for Quality
It comes as no surprise to those in the industry that Life Sciences, and pharma in particular, is currently facing a challenging skills gap – there are too many available positions with not enough manpower to fill them. A report in 2020, which looked into future life science workforces, concluded that the STEM skills gap is estimated to leave 2.4 million positions unfilled in the U.S. between 2018 and 2028, with a potential economic impact of $2.5 trillion [1]. These figures highlight significant skills shortages, lack of effective education policies, and competition from abroad.
What these figures and the skills gap indicate is that the demand for a talented and skilled workforce in Life Sciences and Pharmaceuticals is extraordinary. It is obvious that the need for professionals in Quality Control and Assurance is, and will continue to be, extremely high. Pursuing a career in this field will be highly rewarding with the knowledge that the requirement for skilled talent is dominating the industry. And there are a variety of roles open in both QC and QA to choose from – here are some of them:
Roles within Quality Control:
Quality Technician – Carries out quality testing, whose general tasks would be gathering data, reporting on inspection results (e.g. identifying defects), and writing procedures.
Quality Auditor – Performs audits on products, suppliers, systems, or processes. Other duties include creating reports and following up on audits with corrective actions.
Quality Control Supervisors - Supervisors oversee product testing to make sure procedures are conducted correctly and efficiently. They recommend technology or manufacturing improvements to increase efficiency, cost, and speed.
Quality Control Engineer - Inspects and improves products, and monitors and develops inspection processes. They recommend what inspection and testing equipment to use.
Roles within Quality Assurance:
Quality Assurance Tester – As part of the development team, they design test plans, procedures, and scenarios.
Quality Coordinator – Quality coordinators track and provide information related to quality assurance. They make sure companies follow compliance requirements, such as ISO 9001.
Quality Assurance Manager - Oversees quality assurance processes by encouraging continuous improvement and solving quality problems. Quality managers resolve suppliers' performance issues, recommend corrective actions, and manage direct reports.
Quality Assurance Director - oversees all quality assurance processes, sets policies, creates strategic plans, and develop QA programs to improve quality.
These are just a small selection of roles available within the Quality Management sector, but more examples examples can be found which may or may not have specific roles and responsibilities attributed to them. These are: Quality Specialist, QA Associate, Quality Analyst, and many more.
Quality Skills Required
When it comes to working within the pharmaceutical industry, skills such as organisational ability, leadership, and communication, are all highly transferable and much sought after by employers, and are common across QC and QA. Below are some of the specific skills that each role requires.
Quality Control - Quality control is vital for all raw materials, intermediates, and finished products. Teams of analytical chemists, microbiologists, environmental scientists, and safety experts work closely with manufacturing colleagues to see that every product produced is of the highest standard possible through a series of testing procedures. Some of the key skills they require are:
Attention to detail – Focuses on the identification of defects.
Analytical skills – Applying data analysis techniques and interpreting the data.
Problem solving skills - Working around problems and finding new solutions.
Testing and inspections - Verifying and testing medicine at various stages of production to ensure every product is of the highest quality.
Standards – Ensure all standards by the company, the regulators, and the customer, are adhered to.
Quality Assurance - Quality assurance managers work closely with operations managers to ensure that there is overall control of the manufacture and packaging of the products. A QA specialist's role will include writing and revising control procedures, reviewing batch records for release of material, and completing internal, external, and supplier audits to ensure a high level of quality awareness and compliance.
Attention to detail – Focuses on the prevention of defects.
Decision making – Once the data is interpretated, making the necessary decisions to move forward, or not, in some case.
Testing proficiency - Carrying out thorough testing procedures across whole lifecycle, including root cause analysis.
Investigative ability - Perform thorough investigations in the event of any quality issues or non-compliance
Key Soft Skills to Make you Stand Out
Technical skills and experience, while crucial in the pharmaceutical industry and Life Sciences in general, are necessary when pursuing a career in quality management, but soft skills also play a large part in your own personal growth. Below are some of the relevant soft skills that are applicable to all of the roles mentioned previously:
Excellent communication and teamwork skills to convey complex information clearly and persuasively.
Adaptability and resilience in a constantly changing industry due to regulatory updates, market shifts, and technological advancements.
Ability to work with minimum supervision, prioritise tasks and build cross-functional relationships.
Emotional intelligence enables professionals to build strong relationships, resolve conflicts, and navigate challenging situations.
Strong problem-solving skills enable individuals to analyse complex problems and identify solutions.
Getting started in Quality Control
Quality Control can be a rewarding career if you enjoy working with people, communicating, presenting results, and working to make products better and safer. To work in quality control, you will need (depending on the industry):
In the QC sector, a high school diploma is required for entry-level positions.
A bachelor's degree in needed for advanced positions, depending on the industry.
Licenses and certifications, such as compliance, for some industries and businesses.
Getting started in Quality Assurance
Quality Assurance plays an important role in ensuring that pharmaceutical products meet the highest standards of safety, efficiency, and quality. This fulfilling role means you will need the following educational requirements:
Working in the pharmaceutical industry may a require a bachelor's degree, preferable in chemistry, biology, or pharmacy.
Some positions may require a master's degree or a related advanced degree.
Additional training and certification, such as ISO 9000:2015, may be required.
If you have previous experience in quality management from another sector, then moving into Pharmaceutical Quality Control and Assurance can be an easier transition. As pharma has more stringent compliance and regulatory guidelines because of the human risks associated with it, more certification and training may be required if you are coming from a background of food, cosmetics and medical devices/healthcare.
Registering with Orion Group
If you are thinking of starting a career in Pharmaceuticals in Quality Management, especially in Quality Control and Quality Assurance, then the future looks particularly bright in terms of finding a role to suit you in an industry that is in need of professionals to fill vacant positions.
If any of these roles align with your career aspirations, Orion Group can help you take the next step with our network of experts. We specialise in connecting talented individuals like you with leading companies that value scientific expertise. By registering your CV with us, you’ll gain access to a wide range of Quality Management jobs, ensuring that your skills and experience are matched with the right role.
