Quality Systems Manager

Jobtailor; Rock Hill (SC); On-site; USD 90,000 - 110,000; Full time

Job summary

Jobtailor in Rock Hill, SC seeks a Quality Systems professional to lead quality programs at a plasma donor center. You will supervise the Quality Systems Associate, ensure regulatory compliance, and drive continuous improvement across processes and training.

The role requires cGMP/regulatory knowledge, strong root cause analysis, and ability to work with cross-functional teams to maintain donor safety and product quality.

Qualifications

• Bachelor of Science degree or equivalent
• 2 years of related experience in a medical/cGMP environment
• Experience with plasma or whole blood preferred
• Ability to understand and assess FDA regulations
• Proficiency in root cause analysis and corrective/preventive actions
• High level of proficiency with computers
• Strong mathematics skills
• Willingness to travel for meetings and center support
• Ability to work independently with minimal supervision
• Ability to work with diverse groups to obtain consensus
• Ability to apply abstract principles to solve complex issues
• Exposure to biological fluids, infectious organisms, cold temps, chemicals, moving machinery, and noise; use PPE

Responsibilities

• Evaluate processes 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 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 hiring, development, training, and scheduling
• Oversee audits, including preparation, execution, responses, CAPAs, 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 and process improvements
• Oversee product and biohazard waste shipments, labeling, documentation, and regulatory compliance
• Review unsuitable test results, donor adverse events, 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; initiate nonconformance investigations
• 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 and training are documented
• Hold monthly Quality Meetings to communicate updates and manage action outcomes

Skills

Root Cause Analysis

Corrective Actions

Quality Control

SOP Implementation

Regulatory Compliance

Data Analysis

Collaboration

Independent Work

Problem Solving

Education

Bachelor of Science Degree

Tools

QMS Software

Data Analysis Tools

Training Management Systems

Document Control Systems

Job description

• 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

• 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

Core Competencies

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 Systems
• Regulatory Compliance
• Root Cause Analysis
• CGMP Regulations
• Training Program Oversight

Hard Skills

• Root Cause Analysis
• Corrective Actions
• Quality Control
• Statistical Analysis
• SOP Implementation
• Regulatory Compliance
• Quality Improvement
• Data Analysis
• Audit Preparation
• Process Improvement

Soft Skills

• Collaboration
• Problem Solving
• Independent Work
• Consensus Building
• Communication

Certifications & Qualifications

• Bachelor of Science Degree
• Advanced cGMP Training
• Blood Borne Pathogen Training

Industry Keywords

• Plasma Donation
• Blood Safety
• FDA Regulations
• CGMP Environment
• Medical Compliance

Tools & Technologies

• Quality Management Software
• Data Analysis Tools
• Training Management Systems
• Document Control Systems