Quality Systems & Training Manager

Grifols, S.A; Farmington Hills (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Grifols, S.A. is seeking a Quality Systems & Training Manager to evaluate processes, develop action plans, and coordinate the strategic implementation of quality system processes and corrective actions at the plasma donor center.

You will oversee the center's quality management system, ensure compliance with state, federal, and company SOPs, manage staff training records, and collaborate with the Center Manager to maintain product quality, donor safety, and overall operations.

Qualifications

• Bachelor of Science degree or equivalent.

Responsibilities

• Maintains oversight of the center’s quality management system and drives continuous quality improvement.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements SOPs for quality control and regulatory compliance.
• Maintains oversight of center training program by ensuring compliance and maintaining training records.
• Collaborates with Center Manager to ensure donor center operates with product quality, donor suitability and donor safety.
• Responsible for personnel functions of the Quality Associate, including hiring, training and performance management.
• Oversees all aspects of internal and external audits including audit prep, responses, and corrective actions.
• Investigates deviations and customer complaints, and performs root-cause analysis.
• Reviews donor adverse event reports and related documentation.
• Ensures staff annual training is completed and documented.
• Ensures supplies meet quality requirements and are stored properly; initiates investigations for non-conformance.
• Determines donor suitability activities and manages donor deferrals as appropriate.

Education

Bachelor of Science degree or equivalent

Job description

Grifols, S.A. is seeking a Quality Systems & Training Manager to evaluate processes, develop action plans, and coordinate the strategic implementation of quality system processes and corrective actions at the plasma donor center.

You will oversee the center's quality management system, ensure compliance with state, federal, and company SOPs, manage staff training records, and collaborate with the Center Manager to maintain product quality, donor safety, and overall operations.