Definition of occupation
The Quality Assurance (QA) Manager typically adds value by managing quality on at least three levels. Firstly, they ensure the company has a body of knowledge and quality management tools available from which they can initiate different interventions to provide quality products and services. Secondly, the QA Manager typically collaborates with various process owners within the
organization to ensure that the quality principles are embedded in the end-to-end company work processes. Thirdly, the QA Manager is, directly, and indirectly, responsible for a team of quality management analysts and specialists. QA Managers govern quality management practices within the organization by implementing a Quality Management System (QMS).
The QMS defines company practices, policies, responsibilities, resources, and records that are used to ensure continuous compliance with industry and regulatory standards relevant to the organization’s objectives and practices, in addition to meeting customer needs. These processes are related to establishing internal requirements reflecting regulatory and customer quality requirements for product and service standards, competency and training requirements, standard work processes to be maintained, and quality that must be proved at the product and service levels. When deviances to work processes and/or product and service quality are detected, the quality methodology expects that action will be implemented to correct any deviances and elements of noncompliance. To maintain a consistent level of quality, numerous tools and techniques may be used such as Internal Audits, Statistical Process Controls, root cause analysis, cause and effect diagrams, control charts, Pareto charts, and flow charts.
The QA Manager is also responsible for product release by confirming and attesting to proper manufacturing procedures, quality control, and documentation to provide an audit trail. It is also expected that the QA Manager performs continuous improvement by identifying opportunities in the QMS, which will benefit improvements of the business processes.
Lastly, the QA Manager may be responsible as a manager for the departmental budget, finance and human resources duties, including the hiring of staff, employee performance evaluations, and the training and mentoring of junior staff. The QA Manager may work for Canadian biotechnology organizations of different sizes and in various biotechnology areas, such as:
- Food Processing
- Human and Animal Health
- Life Sciences
- Medical Devices
- Natural Resources