Quality Systems Manager

Grifols

Quality Systems Manager at Grifols overseeing compliance in plasma donor center quality management. Responsible for audits, training, donor safety, and regulatory compliance.

Posted 7/16/2026full-timeStillwater • Oklahoma • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management systems, regulatory compliance, and process improvement within a plasma donor center environment. Proficient in root cause analysis, corrective actions, and maintaining high standards of donor safety and product quality.

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceRoot Cause AnalysisCGMP ExperienceFDA Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlCorrective ActionsProcess ImprovementData AnalysisDocumentation Review

Soft Skills

Interpersonal CommunicationOrganizational AbilitiesProblem-SolvingTime ManagementLeadership

Tools & Technologies

Quality Analysis ReportsTraining SystemsAudit Preparation Tools

Certifications & Qualifications

Bachelor of Science DegreeQuality and Compliance Certification

Industry Keywords

PlasmaWhole BloodCGMPClinical Laboratory Improvement AmendmentsBiohazard Waste Management

About the role

Key responsibilities & impact

Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions at the plasma donor center
Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties
Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance
Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained
Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks
Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required
Continuously assesses, promotes, and improves the effectiveness of the quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations
Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product
Investigates identified trends and performs follow-up on corrective and preventive actions, system implementations, and process improvement plans to measure/determine effectiveness
Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment
Performs a review of the documentation of unsuitable test results and unit lookback information
Performs a review of donor adverse event reports and the applicable related documents
Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as may be required) is completed, documented, and on file
Performs employee training observations to ensure staff competency prior to releasing employees to work independently
Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions
Initiates appropriate investigations if these requirements are not met
Initiates rejection of supplies for non-compliance
Determines donor suitability activities and manages donor deferrals as appropriate
Reviews and approves deferred donor reinstatement activities
Prepares quality analysis reports to track issues and set goals
Does in depth research and analysis to resolve systemic compliance issues
Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented
Holds monthly Quality Meeting to communicate status updates and manage action outcomes
Leads projects and initiatives as requested

Requirements

What you’ll need

Bachelor of Science degree or equivalent
Certified and proficient in quality and compliance
Typically requires 2-5 years of related experience in a medical and/or cGMP regulated environment
Experience with plasma or whole blood
Command of interpersonal communication, organizational and problem-solving abilities
Ability to understand and assess FDA regulations
Strong integrity and commitment to quality and compliance
Full command of mathematics
Legible handwriting
High level of proficiency with computers.
Proficient in root cause analysis and corrective/preventative actions
Ability to balance multiple competing priorities
Strong time management abilities
Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team
Ability to work with minimal supervision.
Ability to travel when needed for meetings, events, and occasional support of other centers.

Benefits

Comp & perks

Relocation Assistance of up to $20K