Quality Systems Manager – Donor Center Compliance

Grifols; Alabama; On-site; USD 90,000 - 130,000; Full time

Job summary

Grifols, an international healthcare company, is seeking a Quality Systems Manager to lead QA/regulatory activities at the Sumter, USA donor center. The role emphasizes strengthening the quality management system, training staff, and ensuring compliance with FDA and cGMP requirements.

The candidate will coordinate corrective actions, perform root cause analyses, and drive continuous improvement while maintaining high standards of product quality and donor safety.

Qualifications

• Bachelor of Science degree or equivalent.
• Equivalency: direct experience or education/experience combinations may be considered.
• Typically 2 years of related experience in a medical and/or cGMP regulated environment; plasma/whole blood preferred.

Responsibilities

• Evaluates processes and coordinates strategic implementation of quality system processes and corrective actions.
• Maintains oversight of the donor center's quality management system and drives continuous quality improvement.
• Directs and monitors processes to ensure compliance with regulations and SOPs.
• Maintains training program oversight and staff competency records.
• Oversees audits, deviations, root cause analyses, and corrective actions.
• Ensures product quality, donor safety, and regulatory compliance across operations.

Skills

FDA regulations

Root cause analysis

Quality systems

Training & mentorship

Regulatory compliance

Interpersonal communication

Problem solving

Time management

Education

Bachelor of Science

Job description

Grifols, an international healthcare company, is seeking a Quality Systems Manager to lead QA/regulatory activities at the Sumter, USA donor center. The role emphasizes strengthening the quality management system, training staff, and ensuring compliance with FDA and cGMP requirements.

The candidate will coordinate corrective actions, perform root cause analyses, and drive continuous improvement while maintaining high standards of product quality and donor safety.