Quality Systems Manager

Grifols

. Evaluate processes, develop action plans, and coordinate strategic implementation of quality system processes and corrective actions at the plasma donor center .

Posted 10/22/2026part-timeBowling Green • Ohio • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management systems, regulatory compliance, and continuous quality improvement within a plasma donor center. Proficient in overseeing training programs, conducting audits, and implementing Standard Operating Procedures (SOPs) to ensure donor safety and product quality.

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceStandard Operating Procedures (SOPs)Root-Cause AnalysisTraining Program Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlContinuous Quality ImprovementAudit ManagementDocumentation ManagementBiohazard Waste ShipmentDonor Suitability KnowledgeCLIA Proficiency TestingCorrective ActionsTrend AnalysisCompetency Observations

Soft Skills

CollaborationLeadershipCommunicationProblem-SolvingTraining and Development

Certifications & Qualifications

Bachelor of Science Degree

Industry Keywords

Plasma Donor CenterState RegulationsFederal RegulationsQuality Analysis ReportsCustomer ComplaintsTraining DocumentationProduct Release RequirementsDeviations ManagementAdverse Event ReportsInternal and External Audits

About the role

Key responsibilities & impact

Evaluate processes, develop action plans, and coordinate strategic implementation of quality system processes and corrective actions at the plasma donor center
Maintain oversight of the center’s quality management system and drive continuous quality improvement
Direct and monitor processes for compliance with state, federal, and company regulations
Implement SOPs for quality control and regulatory compliance
Oversee the center training program, including training records, annual training, and competency observations
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Direct, assign, hire, develop, train, and manage the Quality Associate
Oversee internal and external audits, corrective/preventive actions, and follow-up
Investigate trends, deviations, failures, and customer complaints using root-cause analysis
Oversee product and biohazard waste shipments, including labeling, documentation, and final shipment authorization
Review unsuitable test results, unit lookback information, donor adverse event reports, and related documentation
Ensure supplies and materials meet quality requirements and are properly stored
Prepare quality analysis reports, research systemic compliance issues, and hold monthly Quality Meetings

Requirements

What you’ll need

Bachelor of Science degree or equivalent
Must ensure compliance with all applicable state, federal, and company-designated regulations
Knowledge/application of Standard Operating Procedures (SOPs) for quality control and regulatory compliance
Ability to oversee quality management systems and continuous quality improvement
Ability to oversee training programs, audit training records, and ensure staff competency
Ability to oversee internal and external audits and corrective/preventive actions
Ability to document deviations and customer complaints and perform root-cause analysis
Knowledge of donor suitability, donor deferrals, and donor reinstatement activities
Knowledge of CLIA proficiency testing, complaint investigations, and training documentation
Knowledge of applicable quality, product release, biohazard waste shipment, and storage requirements

Benefits

Comp & perks

Equal employment opportunities and consideration consistent with applicable laws