Quality Systems Manager

Grifols • Bowling Green, OH

8d

About The Position

The Quality Systems Manager evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at a plasma donor center. The role maintains oversight of the center’s quality management and training systems, supports regulatory compliance and continuous quality improvement, and helps ensure product quality, donor suitability, and donor safety. The position supervises the Quality Associate and collaborates with the Center Manager.

Requirements

• Bachelor of Science degree or equivalent.

Responsibilities

• Maintain oversight of the center’s quality management system, address deficiencies promptly, and communicate concerns to appropriate parties.
• Direct and monitor processes for compliance with applicable state, federal, and company-designated regulations; implement Standard Operating Procedures for quality control and regulatory compliance.
• Oversee the center training program, audit training records and files, and ensure staff meet program requirements and are competent in their assigned duties.
• Collaborate with the Center Manager to help ensure product quality, donor suitability, and donor safety.
• Manage personnel functions for the Quality Associate, including work direction and assignment, hiring, development and training, discipline, termination, personnel records, scheduling, and task delegation and follow-up.
• Oversee internal and external audits, including preparation, execution, responses, corrective and preventive actions, assessment, and follow-up.
• Assess and improve quality and training systems by identifying trends, investigating procedural failures, and conducting direct observations.
• Document and investigate deviations and customer complaints, perform root-cause analyses, and assess their relationship to donor safety and product quality.
• Investigate trends and follow up on corrective and preventive actions, system implementations, and process improvement plans to determine effectiveness.
• Oversee product and biohazard waste shipments, ensuring regulatory specifications, product-release requirements, accurate labeling and documentation, and authorization of final shipment.
• Review documentation of unsuitable test results and unit lookback information.
• Review donor adverse-event reports and related documentation.
• Ensure required annual job and center training, including Advanced cGMP and Blood Borne Pathogen training, is completed, documented, and filed.
• Observe employee training to verify staff competency before authorizing employees to work independently.
• Ensure supplies and materials meet quality requirements and are stored under appropriate temperature and facility conditions; initiate investigations when requirements are not met and reject nonconforming supplies.
• Determine donor suitability activities, manage donor deferrals as appropriate, and review and approve deferred-donor reinstatements.
• Prepare quality analysis reports to track issues and set goals; research and analyze systemic compliance issues.
• Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented.
• Hold monthly Quality Meetings to communicate status updates and manage action outcomes.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager