Quality Systems Manager: Plasma Center Excellence

Grifols; Aurora (CO); On-site; USD 69,000 - 103,000; Full time

Benefits offered by this job

Relocation assistance

Medical insurance

Dental insurance

Vision insurance

PTO

Paid holidays

401(K) match

Tuition reimbursement

Job summary

Grifols in Aurora, CO seeks a Quality Systems Manager to lead the donor center's quality management system, drive continuous improvement, and supervise the Quality Systems Associate. The role ensures regulatory compliance, SOP implementation, staff training, and robust audits across the center.

The position requires a BS degree, certification in quality and compliance, and 2–5 years in a cGMP or medical setting, preferably with plasma or whole-blood operations. Relocation support is available.

Qualifications

• Bachelor of Science degree is required or equivalent.
• Certified in quality and compliance.
• Typically 2–5 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or Whole blood is preferred.

Responsibilities

• Maintains oversight of the center’s quality management system and ensures continuous quality improvement by addressing deficiencies.
• Directs and monitors processes to ensure compliance with regulations; implements SOPs for quality control.
• Collaborates with Center Manager to ensure donor center operates with product quality and donor safety in mind.
• Oversees personnel functions for Quality Systems Associate including training and scheduling.
• Oversees audits (internal and external) including preparation, execution, corrective actions and follow-up.
• Performs root-cause analysis for deviations and customer complaints related to donor safety and product quality.
• Reviews donor adverse event reports and related documentation.
• Ensures training is completed and documented for all staff.

Skills

Quality management

Regulatory compliance

cGMP

Audits

Education

Bachelor of Science degree

Job description

Grifols in Aurora, CO seeks a Quality Systems Manager to lead the donor center's quality management system, drive continuous improvement, and supervise the Quality Systems Associate. The role ensures regulatory compliance, SOP implementation, staff training, and robust audits across the center.

The position requires a BS degree, certification in quality and compliance, and 2–5 years in a cGMP or medical setting, preferably with plasma or whole-blood operations. Relocation support is available.