Quality Assurance Manager (No. JLAL160530)
Quality Assurance / Regulatory Affairs Senior Manager
- Develop site quality assurance strategy, create a culture for quality based on the processes map and measurement indicators.
- Calibrate the quality assurance practice in the region, and optimize the existing system and continuous improvement on the quality assurance system.
- Define the quality assurance policy and process, lead the implementation of quality assurance models and system that can guarantee to the organization customer satisfaction, continuous improvement and organizational effectiveness in order to achieve maximum competitiveness.
- Establish operating budgets, monitor the cost, effectiveness, and reliability of quality assurance activities to optimize resources, priorities spending, and ensure that targets and standards are met.
- Evaluate the results of quality assurance activities and prepare recommendations for executives about significant changes that need to be made to the organization’s operation processes, systems, technology, raw materials, inputs, or vendors, especially in manufacturing and R&D area.
- Connect customer needs with the conditions of the production process and define product guidelines and criteria and the conditions of the manufacturing process.
- Liaise with functional and operational area managers to develop schedules, projects plan, and cost estimates for implementing new activities, procedures, or methods to improve the quality and performance of the organization’s products.
- Research, evaluate, and recommend investments in technology, capital, equipment, systems, or other assets that will improve quality of the organization’s raw material, in-process products, and finished products.
- Liaise with external suppliers to ensure that their products meet the organization’s quality standards and that the organization receives satisfactory standards of service.
- Lead, direct, evaluate, and develop a team of quality professionals to ensure that quality assurance activities meet established targets and standards.
EDUCATION AND EXPERIENCE
- Quality engineer, auditor or other quality related certificate.
- More than 10 years’ quality management experiences, and more than three years pharmacy or medical devices international company quality management experiences. Familiar with the regulation code of ISO9000, ISO13485, QSR, GMP, CFR820, IVDD etc. FDA audit experience is preferred.
- Bachelor degrees or above, majored in biochemistry, pharmacology etc.
- Excellent leadership and coordination skill, result oriented.
- Advanced level of English