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 10/14/2026full-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 corrective actions within a plasma donor center environment. Proficient in training program oversight, root cause analysis, and maintaining product quality and donor safety.

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceRoot Cause AnalysisCGMP ExperienceTraining Program Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlCorrective ActionsProcess ImprovementData AnalysisFDA RegulationsMathematics ProficiencyDocumentationAudit ManagementDonor Suitability AssessmentBiohazard Waste Management

Soft Skills

Organizational SkillsProblem-SolvingTime ManagementInterpersonal CommunicationTeam Collaboration

Tools & Technologies

Quality Analysis SoftwareTraining Management SystemsCompliance Tracking Tools

Industry Keywords

Plasma DonationCGMPCLIABiological FluidsInfectious Organisms

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 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, audit training records, and promote staff competency
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Manage 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, corrective/preventative actions, and follow-up
Assess trends, investigate procedural failures, and improve quality and training systems
Document deviations and customer complaints and perform root-cause analysis
Investigate trends and assess the effectiveness of corrective/preventative actions and process improvement plans
Oversee product and biohazard waste shipments, including labeling, documentation, regulatory specifications, and final authorization
Review unsuitable test results, unit lookback information, donor adverse event reports, and related documentation
Ensure annual job and center training is completed and documented
Perform employee training observations before independent work release
Ensure supplies and materials meet quality requirements and are properly stored; initiate investigations or rejection for non-conformance
Determine donor suitability activities and manage donor deferrals and reinstatements
Prepare quality analysis reports and research systemic compliance issues
Ensure CLIA proficiency test surveys, complaint investigations, and training are 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
Proficient in root cause analysis and corrective/preventative actions
High level of proficiency with computers
Strong organizational, problem-solving, time management, and interpersonal communication abilities
Full command of mathematics
Ability to work with minimal supervision
Ability to travel when needed for meetings, events, and occasional support of other centers
Ability to work in office and/or laboratory/manufacturing environments with exposure to biological fluids, infectious organisms, cold temperatures, chemicals, machinery, and noise
Ability to use required personal protective equipment
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 work with diverse groups to obtain consensus

Benefits

Comp & perks

Medical benefits
PTO
Up to 5% 401K match
Tuition reimbursement
Opportunities for professional growth and career progression
Family-like culture