Plasma Quality Systems Lead

Grifols, S.A; Surprise (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Grifols, S.A. is seeking a Quality Systems Manager for the Plasma Center in Surprise, AZ. The role evaluates processes, develops action plans, and coordinates strategic implementation of system processes and corrective actions under the Regional Quality Manager.

The position requires overseeing the quality management system, ensuring regulatory compliance, and leading training and audit activities within the donor center. A Bachelor of Science and cGMP experience are required.

Qualifications

• Bachelor's degree in science 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.
• Equivalency may be considered with related education and experience.

Responsibilities

• Maintains oversight of the center’s quality management system and ensures continuous quality improvement.
• Directs processes to ensure compliance with state, federal, and company regulations; implements SOPs for quality control and regulatory compliance.
• Collaborates with Center Manager to ensure donor center operates with product quality, donor suitability and donor safety.
• Oversees audits and CAPA implementation and follow-up.
• Documents investigations and performs root-cause analysis for deviations and customer complaints.
• Holds monthly Quality Meetings to communicate status updates.

Skills

Interpersonal skills

Organizational skills

Problem solving

FDA regulations

Quality compliance

Mathematics

Computer skills

Root cause analysis

Time management

Travel

Education

Bachelor of Science

Certified in quality & compliance

Job description

Grifols, S.A. is seeking a Quality Systems Manager for the Plasma Center in Surprise, AZ. The role evaluates processes, develops action plans, and coordinates strategic implementation of system processes and corrective actions under the Regional Quality Manager.

The position requires overseeing the quality management system, ensuring regulatory compliance, and leading training and audit activities within the donor center. A Bachelor of Science and cGMP experience are required.