Quality Systems Manager

GRIFOLS, S.A.•Bowling Green, OH

10d

About The Position

The Quality Systems & Training 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 system and training program, supports regulatory compliance, and works with the Center Manager to maintain product quality, donor suitability, and donor safety. The manager is responsible for personnel functions of the Quality Associate. The posting does not specify who this position reports to.

Requirements

Bachelor of Science degree or equivalent.

Responsibilities

Maintain oversight of the center’s quality management system and drive continuous quality improvement by addressing deficiencies promptly and communicating concerns to appropriate parties.
Direct and monitor processes to ensure compliance with applicable state, federal, and company-designated regulations; implement quality-control and regulatory-compliance SOPs.
Oversee the center training program, ensure program compliance and staff competency, and maintain and audit training records and files.
Collaborate with the Center Manager to support donor-center operations that maintain product quality, donor suitability, and donor safety.
Manage personnel functions for the Quality Associate, including work direction and assignment, hiring, development and training, disciplinary actions, termination, personnel records, scheduling, and task delegation and follow-up.
Oversee internal and external audits, including preparation, execution, responses, corrective and preventive action implementation and 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, and perform root-cause analysis related to donor safety and product quality.
Investigate trends and follow up on corrective and preventive actions, system implementations, and process-improvement plans to assess effectiveness.
Oversee product and biohazard waste shipments, ensuring regulatory specifications, product-release requirements, accurate labeling and documentation, and authorization of final shipment.
Review documentation for unsuitable test results and unit lookback information.
Review donor adverse-event reports and related documentation.
Ensure required job and annual center training, including Advanced cGMP and Blood Borne Pathogen training, is completed, documented, and filed.
Observe employee training to verify staff competency before releasing employees to work independently.
Verify that ordered supplies and materials meet quality requirements and are stored in 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 reinstatement activities.
Prepare quality-analysis reports to track issues and set goals, and conduct in-depth research and analysis to resolve 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.