Quality Systems Manager

Grifols

Quality Systems Manager overseeing quality systems, audits, training, and compliance at Grifols’ plasma donor center. Supporting donor safety and product quality in Rock Hill.

Posted 8/24/2026full-timeRock Hill • South Carolina • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management systems, regulatory compliance, and continuous quality improvement within a cGMP regulated environment. Proficient in root cause analysis, corrective actions, and training program oversight to ensure donor safety and product quality.

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceRoot Cause AnalysisCGMP RegulationsTraining Program Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Root Cause AnalysisCorrective ActionsQuality ControlStatistical AnalysisSOP ImplementationRegulatory ComplianceQuality ImprovementData AnalysisAudit PreparationProcess Improvement

Soft Skills

CollaborationProblem SolvingIndependent WorkConsensus BuildingCommunication

Tools & Technologies

Quality Management SoftwareData Analysis ToolsTraining Management SystemsDocument Control Systems

Certifications & Qualifications

Bachelor of Science DegreeAdvanced cGMP TrainingBlood Borne Pathogen Training

Industry Keywords

Plasma DonationBlood SafetyFDA RegulationsCGMP EnvironmentMedical Compliance

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
Ensure compliance with applicable state, federal, and company regulations and implement SOPs for quality control and regulatory compliance
Oversee the center training program, audit training records, and ensure staff competency
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Direct personnel functions for the Quality Systems Associate, including work assignment, hiring, development, training, discipline, termination, scheduling, and task follow-up
Oversee internal and external audits, including preparation, execution, responses, corrective/preventative actions, assessment, and follow-up
Identify trends, investigate procedural failures, and improve quality and training systems
Document deviations and customer complaints and perform root-cause analysis
Investigate trends and follow up on corrective/preventative actions, system implementations, and process improvement plans
Oversee product and biohazard waste shipments, including labeling, documentation, regulatory compliance, and final shipment authorization
Review unsuitable test results, unit lookback information, donor adverse event reports, and related documentation
Ensure annual training, including Advanced cGMP and Blood Borne Pathogen training, is completed and documented
Observe employee training to confirm competency before independent work
Ensure supplies meet quality requirements and are properly stored; investigate nonconformance and initiate supply rejection
Determine donor suitability activities and manage donor deferrals and reinstatements
Prepare quality analysis reports and conduct research to resolve systemic compliance issues
Ensure CLIA proficiency test surveys, complaint investigations, and training are documented
Hold monthly Quality Meetings to communicate updates and manage action outcomes

Requirements

What you’ll need

Bachelor of Science degree or equivalent
Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of stated requirements
Typically requires 2 years of related experience in a medical and/or cGMP regulated environment
Experience with plasma or whole blood preferred
Ability to understand and assess FDA regulations
Proficiency in root cause analysis and corrective/preventative actions
High level of proficiency with computers
Strong mathematics skills
Ability to travel when needed for meetings, events, and occasional support of other centers
Ability to work independently with minimal supervision
Ability to work with diverse groups to obtain consensus
Ability to apply abstract principles to solve complex conceptual issues
Ability to perform the stated occupational demands, including exposure to biological fluids, infectious organisms, cold temperatures, chemicals, moving machinery, and noise; use required PPE; sit for 6–8 hours daily; perform repetitive hand movements; lift up to 35 lbs; and drive to site locations with occasional travel within the United States

Benefits

Comp & perks

Medical insurance
PTO
Up to 5% 401(k) match
Tuition reimbursement
Opportunities for professional growth and career progression
Family-like company culture