Quality Systems Manager

Grifols; North Carolina; On-site; USD 70,000 - 90,000; Full time

Job summary

A global healthcare company is seeking a Quality Systems Manager to ensure compliance and oversee quality management systems at their donor center. The ideal candidate will have a Bachelor’s degree and 2 years of experience in a regulated environment, preferably with plasma or whole blood. Responsibilities include coordinating audits, training staff, and improving quality systems. Benefits include medical coverage, PTO, and a 401K match program.

Benefits

Medical benefits

PTO

401K match

Tuition reimbursement

Qualifications

• Typically requires 2 years of related experience in a medical and/or cGMP-regulated environment.
• Experience with plasma or whole blood is preferred.

Responsibilities

• Evaluate processes and develop action plans for quality system processes.
• Maintain oversight of the center’s quality management system.
• Ensure compliance with regulatory standards and implement SOPs.
• Conduct audits and manage training compliance for staff.

Skills

Interpersonal skills

Organizational skills

Problem-solving abilities

Understanding of FDA regulations

Data interpretation

Root-cause analysis

Education

Bachelor of Science degree or equivalent

Job description

Overview

Join to apply for the Quality Systems Manager role at Grifols. Grifols is a global healthcare company focused on improving health and well-being with leadership in plasma-derived medicines and transfusion medicine, operating in more than 110 countries.

Location: North America, USA, Greenville, NC. This is a full-time role in quality systems within a donor center environment.

Primary Responsibilities

• Evaluates processes, develops action plans, and coordinates the strategic implementation of quality 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 ensuring center compliance with applicable state, federal, and company-designated regulations; implements SOPs for quality control and regulatory compliance.
• Maintains oversight of the center training program, ensuring compliance with requirements and maintaining training records and files.
• Collaborates with the Center Manager to assure product quality, donor suitability, and donor safety are maintained.
• Oversees personnel functions of the Quality Systems Associate, including work assignments, hiring, development, training, disciplinary actions, and records management.
• Oversees all aspects of internal and external audits, including preparation, execution, corrective/preventive actions, and follow-up.
• Continuously assesses and improves effectiveness of quality and training systems through trend analysis, investigation of procedure failures, and direct observations.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to donor safety and product quality.
• Investigates trends and follows up on corrective/preventive actions, system implementations, and process improvement plans to measure effectiveness.
• Oversees product and biohazard waste shipments ensuring regulatory specifications, proper labeling, documentation, and final shipment authorization.
• Reviews documentation of unsuitable test results, unit lookback information, and donor adverse event reports as applicable.
• Ensures annual training (e.g., Advanced cGMP, Blood Borne Pathogen) is completed, documented, and on file; conducts employee training observations to verify competency before releasing staff to work independently.
• Ensures all supplies meet quality requirements prior to use, proper storage conditions, and initiates investigations or rejection for non-conformance.
• Determines donor suitability activities, manages donor deferrals, and reviews/approves deferred donor reinstatement.
• Prepares quality analysis reports to track issues and sets goals; conducts in-depth research and analysis to resolve systemic compliance issues.
• Ensures CLIA proficiency test surveys, complaint investigations, and training are properly documented.
• Holds monthly Quality Meetings to communicate status updates and manage action outcomes.

Qualifications

• Bachelor of Science degree or equivalent; equivalency may be considered (e.g., related experience, alternate education).
• Typically requires 2 years of related experience in a medical and/or cGMP-regulated environment; experience with plasma or whole blood is preferred.

Knowledge, Skills, And Abilities

• Strong interpersonal, organizational, and problem-solving abilities; ability to understand FDA regulations; high integrity and commitment to quality.
• Proficiency in mathematics, data interpretation, root-cause analysis, and corrective/preventive actions.
• Ability to balance multiple priorities, manage time effectively, and work with minimal supervision; willingness to travel for meetings and site support.
• Work environment includes office and laboratory/manufacturing settings with exposure to biological materials, chemicals, and equipment; capable of lifting up to 35 lbs; ability to communicate complex information clearly.

Benefits

We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to professional growth and career progression within Grifols’ global, family-like culture.

EEO Statement

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, protected veteran status, disability, or other protected characteristics. We comply with applicable laws in all locations.