Quality Systems Manager

Role Summary

Quality Systems Manager (QSM) at Grifols, responsible for leading and overseeing quality system processes, training, audits, and continuous improvement to ensure product quality, donor safety, and regulatory compliance at the plasma donor center. Drives root cause analysis, CAPAs, and performance metrics to maintain high standards of quality and compliance. Works with center leadership to align quality initiatives with operational goals.

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, addressing deficiencies promptly and communicating concerns.
• Directs and monitors processes to ensure center compliance with applicable regulations; implements SOPs for quality control and regulatory compliance.
• Maintains oversight of the center training program, ensuring compliance with requirements and maintaining training records.
• Collaborates with Center Manager to ensure donor center operations maintain product quality, donor suitability, and donor safety.
• Oversees personnel functions of the Quality Systems Associate, including workload, hiring, development, training, disciplinary actions, and records.
• Oversees audits (internal and external): preparation, execution, response, corrective/preventive actions, and follow-up.
• Continuously assesses and improves quality and training systems through trend recognition and investigation of failures.
• 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 actions, system implementations, and process improvement plans.
• Oversees product and biohazard waste shipments, ensuring regulatory compliance and proper labeling/documentation.
• Reviews documentation of unsuitable test results, unit lookback information, and donor adverse event reports.
• Ensures annual training for staff (e.g., Advanced cGMP, Blood Borne Pathogen) is completed and on file; conducts training observations to verify competency.
• Ensures supplies meet quality requirements, properly stored, and initiates investigations or rejects non-conforming supplies.
• Determines donor suitability activities and manages donor deferrals; reviews and approves deferred donor reinstatement.
• Prepares quality analysis reports, conducts in-depth research to resolve systemic compliance issues.
• Ensures CLIA proficiency test surveys, complaint investigations, and training are properly documented.
• Conducts monthly Quality Meetings to communicate status updates and manage action outcomes.

Qualifications

• Bachelor of Science degree or equivalent. Equivalency 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.

Knowledge, Skills, And Abilities

• Strong interpersonal, organizational, and problem-solving abilities; ability to understand and assess FDA regulations.
• High integrity and commitment to quality and compliance; proficiency in mathematics and data analysis.
• Proficient in root cause analysis and corrective/preventive actions; ability to manage multiple priorities and work with minimal supervision.
• Strong computer skills; ability to communicate complex information clearly; experience working with center leadership teams.
• Willingness and ability to travel as needed for meetings and occasional support of other centers.

Education

• Bachelor of Science degree or equivalent.

Additional Requirements

• Work is performed in an office and/or a laboratory/manufacturing environment with potential exposure to biological fluids and other hazards; use of personal protective equipment as required.
• Physical demands include occasional lifting up to 35 lbs, standing/walking, and repetitive hand movements; travel within the United States may be required.