Quality Systems Manager

Jobtailor

El Paso (TX)

On-site

USD 75,000 - 110,000

Full time

6 days ago

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Job summary

Jobtailor is seeking a Quality Assurance/Regulatory professional to oversee the plasma donor center's quality management system and drive continuous improvement. You will coordinate corrective actions, ensure donor safety, and maintain compliance with FDA and cGMP standards in a dynamic environment.

Responsibilities include leading audits, training staff, and implementing SOPs for quality control, with travel as needed.

Qualifications

Bachelor of Science degree or equivalent.
Certified in quality and compliance.
2–5 years of related experience in medical and/or cGMP environment.
Experience with plasma or whole blood.
Ability to understand and assess FDA regulations.

Responsibilities

Evaluate processes and coordinate corrective actions at the plasma donor center.
Maintain quality management system and drive continuous improvement.
Lead audits and respond with corrective/preventive actions.
Ensure donor safety and product quality through SOPs.
Oversee training, staffing, and performance actions.

Skills

Quality management systems

Regulatory compliance

Root cause analysis

cGMP environment

Interpersonal communication

Time management

Problem solving

Donor suitability assessment

Training and development

Process improvement

Education

Bachelor of Science Degree

Tools

Quality Analysis Software

Compliance Management Tools

Data Management Systems

Job description

Evaluate processes, develop action plans, and coordinate strategic implementation of system processes and corrective actions at the plasma donor center
Maintain oversight of the center’s quality management system and ensure continuous quality improvement
Address deficiencies promptly and communicate concerns to appropriate parties
Direct and monitor processes to ensure compliance with state, federal, and company regulations
Implement SOPs for quality control and regulatory compliance
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Direct and manage Quality Systems Associate personnel functions, including hiring, training, scheduling, delegation, and performance actions
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 investigation, and observations
Document deviations and customer complaints and perform root-cause analysis
Investigate trends and follow up on corrective/preventive actions, system implementations, and process improvement plans
Oversee product and biohazard waste shipments, including regulatory compliance, labeling, documentation, 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, documented, and maintained
Perform employee training observations to verify staff competency
Ensure supplies and materials meet quality requirements and are properly stored; initiate investigations or rejection when necessary
Determine donor suitability 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 documented
Hold monthly Quality Meetings and manage action outcomes
Lead projects and initiatives as requested

Requirements

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
Directly related experience or a combination of directly related education, experience, and/or competencies may be considered in place of stated requirements
Ability to understand and assess FDA regulations
Proficiency in root cause analysis and corrective/preventative actions
High level of proficiency with computers
Strong interpersonal communication, organizational, and problem-solving abilities
Full command of mathematics
Ability to balance multiple competing priorities
Strong time management abilities
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, including exposure to biological fluids, infectious organisms, chemicals, cold, noise, and moving machinery
Ability to use required personal protective equipment
Ability to sit for 6–8 hours per day
Ability to lift and carry up to 35 lbs
Ability to travel within the United States occasionally

Core Competencies

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 donor safety and product quality.

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