Quality Systems Manager

About This Role

This Quality Systems Manager role involves evaluating processes, developing action plans, and coordinating the strategic implementation of quality system processes and corrective actions at a plasma donor center. The manager maintains oversight of the center's quality management system, ensuring continuous quality improvement and compliance with regulations. The role also includes managing personnel functions for Quality Systems Associates and overseeing internal and external audits.

Responsibilities

• Evaluate processes, develop action plans, and coordinate the strategic implementation of quality system processes and corrective actions at the plasma donor center
• Maintain oversight of the center’s quality management system and ensure continuous quality improvement by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties
• Direct and monitor processes and ensure center compliance with all applicable state, federal, and company-designated regulations
• Implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance
• Maintain oversight of the center training program by ensuring compliance to program requirements, promoting staff competency in their assigned job duties
• Maintain and audit training records and files
• Collaborate with the Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability, and donor safety are maintained
• Responsible for the personnel functions of the Quality Systems Associate, including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule, and delegation/follow-up of tasks
• Responsible for oversight of all aspects of internal and external audits, including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required
• Continuously assess, promote, and improve the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations
• Document, investigate, and perform root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product
• Investigate identified trends and perform follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness
• Oversee product and biohazard waste shipments: Ensure shipments meet regulatory specifications and product release requirements; ensure accurate labeling and documentation and authorize final shipment
• Perform a review of the documentation of unsuitable test results and unit lookback information