Traditionally the role and function of the quality assurance director fell on the shoulders of Engineering Manager-type roles. The Quality assurance directors typically plan, organize, direct, control and evaluate the activities related to quality and/or engineering department, service or firm.
They are employed by a wide range of private sector and government establishments and by consulting engineering and scientific research companies.
Engineering managers with diverse backgrounds and training, are familiar with and perform some or all of the following duties:
- Plan, organize, direct, control and evaluate the activities and operations related to quality control and assurance
- Develop and implement policies, standards and procedures for the engineering and technical work performed in the department, service, laboratory or firm
- Consult and negotiate with clients to prepare specifications, explain proposals and present engineering reports and findings
- Assign, co-ordinate and review the technical work of the department or project teams
- Recruit personnel and oversee development and maintenance of staff competence in required areas
- May participate directly in the design, development and inspection of technical projects or in the engineering work of the department.
The Quality Assurance managerial function entitled typically as Director of Quality Assurance can be held responsible for a vast array of quality-related issues, processes, operations, improvement projects and initiatives, results and outcome. Tasks and duties include responsibility for safety, compliance and quality of all processes and outcomes/manufactured products. The director QA may also be responsible for developing communications, education and training to instill a compliance perspective in every employees activities, establishes relationships and processes for building quality into the products through interactions with Research and Development, Package Engineering and Operations, develops processes and oversees the review of data from physical, chemical, and microbiological testing of finished product and components, stability testing, in-process testing, quality inspections, and release of raw materials, labels, packaging components, and finished product for example, establishes processes to review and approve procedures, validation protocols, validation results, and specifications as required assuring compliance and product quality standards are in place by the time of product validation, establishes and operates change control systems to assure compliance for the facility, equipment, processes and acceptance limits.
The Director QA must be a strong advocate of compliance, a good trainer and leader, and an accomplished manager of technical resources with a proven record in building and motivating successful Quality Assurance efforts. An in-depth knowledge of regulatory requirements and their interpretation such as current Good Manufacturing Practices, Good Laboratory Practices, Stability Guidelines, validation, cleaning validation, facilities, equipment and other requirements as they relate to the production of pharmaceutical products, is required. Must have expert knowledge of development, production and control systems, have training, education and experience in Quality Assurance. Must possess sound reasoning ability, analytical, and creative skills to investigate systems problems in order to recommend and implement solutions.
A bachelor’s degree in engineering or a college diploma in engineering technology and/or certification as a quality assurance professional is required. Extensive experience in an engineering discipline, including supervisory experience, is required. Registration as a Professional Engineer (P. Eng.) by a provincial or territorial association of professional engineers or certification as an engineering technologist (CET) is usually required. Mobility to other technical managerial positions or to research or senior management positions is possible with experience.
The Director QA must also have a working technical knowledge of systems, statistics, auditing and quality improvement processes. At least a Bachelors degree or higher in a scientific/technical area of study with a couple of years demonstrable and successful experience in the Quality Assurance field. Also recommended is an advanced degree in a technical area (chemistry, biology, engineering, mathematics or statistics, pharmaceutical sciences) an M.S. or a Ph.D. degree and at least 12 years experience would be considered minimum requirements for some positions.
The Director QA must also possess good managerial skills in areas such as personnel motivation, planning, finance, goal setting and problem solving, be flexible, willing to travel and able to accommodate the rigorous schedule needed for a QA organization that supports a 24/7 manufacturing operation from time to time.
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