PRINCIPAL OBJECTIVE OF THE POSITION:
As the Quality Systems Manager, you are responsible for the successful implementation, maintenance, and continuous improvement of the quality systems of the laboratories, including the management of qualified, competent personnel. Even though you have the option to delegate some of your responsibilities, you will remain responsible and must ensure that all the duties are properly performed and applicable regulations are met. It is your responsibility to ensure that the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable test results.
MAJOR DUTIES AND RESPONSIBILITIES
• Provides leadership in the Quality Assurance department to promote a complete state of compliance in incumbent and future testing operations.
• Responsible for the overall success of the Quality Management System (QMS).
• Informs Executive Leadership of issues, concerns, or problems that might lead to quality failures before they happen.
• Manages expenses to the approved QA/RA budget.
• With the help of Operations personnel, ensures that physical laboratory is safe and conditions appropriate to provide consistent, timely and quality results.
• Develops, monitors, and makes continuous improvements in the Quality Assurance department based on KPls and other metrics. Will provide data and metrics to leadership for Management Review.
• Implements continuous quality improvements processes and measures effectiveness.
• Leads regulatory as well as customer audits as required. Will be responsible for the responses and corrective actions for any audit non-conformances.
• Responsible for all elements of the CA/PA system.
• Responsible for the administration of the customer complaint system including correspondence and liaising with clients.
• Ensures laboratory adherence to Good Laboratory Practices and Standard Operating Procedures (SOPs).
• Manages the document control system including the drafting, approval, and monitoring or laboratory SOPs and quality records/documents.
• Responsible for the approval of vendors and suppliers as well as maintaining the approved supplier list.
• Hires, integrates, and develops high quality talent, capable of delivering against the department goals and objectives.
• Develops our next generation of leaders through mentorship, training, coaching and feedback.
• Working with R&D, efficiently transfers method changes, updates, and developments into laboratory practice.
• Other Quality Management tasks/skills as required.
KNOWLEDGE AND SKILL
A minimum of 8 years’ experience in quality management roles within regulated laboratory testing including the supervision of staff.