Quality Systems Manager - Plasma Center

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

Benefits offered by this job

Medical, Dental, Vision

PTO & Holidays

401(K) match

Job summary

Grifols, a global healthcare company, is seeking a Quality Systems Manager for the Portland donor center. You will oversee the quality management system, drive regulatory compliance, and lead audits to ensure product safety and donor protection.

The role requires 2–5 years in a medical/cGMP environment, a BS degree, and strong analytical abilities. Travel to sites in the region may be required; salary ranges from $68,640 to $102,960 with bonus eligibility up to 20%.

Qualifications

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.

Responsibilities

• Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
• 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.
• Collaborates with Center Manager to ensure donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
• Oversees the Quality Systems Associate including hiring, training, performance, and scheduling.
• Oversees audits including preparation, execution, corrective actions, and follow-up.
• Performs root-cause analysis for deviations and customer complaints relating to donor safety and product quality.
• Reviews donor adverse event reports and related documents.
• Ensures annual training is completed and documented.
• Ensures supplies meet quality requirements and proper storage conditions.
• Determines donor suitability activities and manages donor deferrals as appropriate.
• Prepares quality analysis reports and conducts in-depth investigations to resolve systemic issues.
• Holds monthly Quality Meetings to communicate status updates.

Education

Bachelor of Science degree or equivalent

Certified and proficient in quality and compliance

Job description

Grifols, a global healthcare company, is seeking a Quality Systems Manager for the Portland donor center. You will oversee the quality management system, drive regulatory compliance, and lead audits to ensure product safety and donor protection.

The role requires 2–5 years in a medical/cGMP environment, a BS degree, and strong analytical abilities. Travel to sites in the region may be required; salary ranges from $68,640 to $102,960 with bonus eligibility up to 20%.