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 10/6/2026full-timeGoldsboro • North Carolina • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceRoot Cause AnalysisTraining Program OversightFDA Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlCorrective ActionsProcess ImprovementData AnalysisMathematics ProficiencyTrend RecognitionDocumentationInvestigative TechniquesAudit PreparationCGMP Standards

Soft Skills

CommunicationCollaborationProblem SolvingIndependenceConsensus Building

Tools & Technologies

Quality Analysis SoftwareTraining Management SystemsDocument Management Systems

Certifications & Qualifications

Bachelor of Science Degree

Industry Keywords

Plasma DonationBiological FluidsInfectious OrganismsQuality ImprovementDonor Safety

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 ensure continuous quality improvement
Direct and monitor processes for compliance with state, federal, and company regulations
Implement Standard Operating Procedures for quality control and regulatory compliance
Oversee the center training program, including training records, files, and staff competency
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Manage Quality Systems Associate personnel functions, including work assignment, hiring, development, training, discipline, termination, scheduling, and follow-up
Oversee internal and external audits, including preparation, execution, responses, corrective/preventive actions, and follow-up
Assess and improve quality and training systems through trend recognition, failure investigations, and direct observations
Document, investigate, and perform root-cause analysis for deviations and customer complaints
Investigate trends and follow up on corrective and preventive actions, system implementations, and process improvement plans
Oversee product and biohazard waste shipments, including regulatory compliance, labeling, documentation, and final shipment authorization
Review unsuitable test results, unit lookback information, donor adverse event reports, and related documentation
Ensure annual job and center training is completed, documented, and filed
Perform employee training observations before releasing employees to work independently
Ensure supplies and materials meet quality requirements and are stored appropriately; initiate investigations and reject non-conforming supplies
Determine donor suitability activities and manage donor deferrals and reinstatement approvals
Prepare quality analysis reports and conduct research 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

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 the 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
Full command of mathematics
High level of proficiency with computers
Proficient in root cause analysis and corrective/preventative actions
Ability to travel when needed for meetings, events, and occasional support of other centers
Ability to work in an office and/or laboratory/manufacturing environment
Ability to handle exposure to biological fluids, infectious organisms, extreme cold, production chemicals, moving machinery, and high noise levels
Personal protective equipment required, including protective eyewear, garments, and gloves
Ability to sit for 6–8 hours per day
Ability to perform repetitive hand movements
Ability to lift and carry up to 35 lbs
Ability to drive to site locations and travel occasionally within the United States
Ability to communicate complex information and understand spoken information
Ability to work independently with little guidance
Ability to interact with diverse groups and obtain consensus
Ability to apply abstract principles to solve complex conceptual issues

Benefits

Comp & perks

Medical benefits
PTO
Up to 5% 401K match
Tuition reimbursement
Professional growth opportunities
Career progression opportunities
Family-like culture