Quality Systems Lead – Plasma Center

Grifols, S.A; Aurora (IL); On-site; USD 69,000 - 103,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Grifols, S.A. in Aurora, CO seeks a Quality Systems Manager to oversee the donor center's quality management system, ensure compliance with FDA and cGMP standards, and lead audits and corrective actions.

A Bachelor of Science with quality certifications is required, plus 2–5 years in regulated environments, preferably plasma-related. This role offers relocation assistance up to $20K and eligibility for a 20% bonus pool.

Qualifications

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• 2-5 years of related experience in a medical and/or cGMP environment.
• Experience with plasma or whole blood.

Responsibilities

• Maintains oversight of the quality management system and ensures continuous quality improvement.
• Directs processes and ensures center compliance with state, federal, and company regulations; implements SOPs for quality control.
• Collaborates with Center Manager to maintain product quality, donor suitability and safety.
• Oversees Quality Systems Associate: direction, hiring, training, scheduling, and review.
• Oversees internal/external audits, corrective actions, and follow-up.
• Promotes and improves quality and training systems; investigates failures and trends.
• Documents investigations and performs root-cause analysis for deviations and complaints.
• Manages donor center safety and product release documentation; oversees waste shipments.

Skills

Quality systems

Regulatory compliance

Root cause analysis

cGMP

Auditing

SOPs

Education

Bachelor of Science degree or equivalent

Certified and proficient in quality and compliance

Job description

Grifols, S.A. in Aurora, CO seeks a Quality Systems Manager to oversee the donor center's quality management system, ensure compliance with FDA and cGMP standards, and lead audits and corrective actions.

A Bachelor of Science with quality certifications is required, plus 2–5 years in regulated environments, preferably plasma-related. This role offers relocation assistance up to $20K and eligibility for a 20% bonus pool.