Center Quality Assurance Manager: Plasma & Compliance

KEDPLASMA; Hendersonville (TN); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health coverage

Life insurance

PTO & holidays

Training programs

Employee discounts

Job summary

Kedplasma is seeking a Quality Assurance Manager to lead quality initiatives across plasma collection operations. You will manage audits, documentation, training, product release, and regulatory readiness, with authority to stop production or shipments if donor or product safety is at risk.

You’ll collaborate with the Center Manager, oversee CLIA testing, investigations, root-cause analysis, and certification tracking while driving continuous improvement and compliance with FDA/EU cGMP standards.

Qualifications

• Bachelor’s degree in healthcare, life sciences, or related field preferred (or equivalent experience).
• 3–5 years of experience in the plasma industry or biomedical field preferred.
• Minimum 1 year of experience in a regulated industry; cGMP experience strongly preferred.
• Strong understanding of FDA, EU, and industry regulations.
• Excellent organizational, analytical, and documentation skills.
• Willingness to travel to other plasma centers and Kedrion locations as needed.

Responsibilities

• Oversee all quality operations at the plasma center, ensuring compliance with FDA, EU GMP, cGMP, and internal standards.
• Review plasma collection records and activities to verify accuracy and adherence to SOPs.
• Investigate deviations and implement corrective actions to maintain compliance.
• Conduct audits and evaluations of procedures, equipment, and documentation.
• Monitor and report test results, quality control records, and preventive maintenance logs.
• Evaluate staff competency through direct observation, written assessments, and proficiency testing.
• Ensure proper documentation and recordkeeping for all quality-related activities.
• Oversee plasma release and shipment verification, ensuring all specifications are met.
• Lead CLIA proficiency testing, complaint investigations, and certification tracking.
• Analyze quality data and trends to identify opportunities for improvement.
• Maintain readiness for internal and external audits and inspections.
• Collaborate with leadership to promote a culture of continuous improvement and regulatory excellence.

Skills

Quality leadership

Auditing

Regulatory readiness

Documentation

Team leadership

Education

Bachelor’s degree in healthcare/life sciences or related field

Tools

Microsoft Office

Data entry systems

Job description

Kedplasma is seeking a Quality Assurance Manager to lead quality initiatives across plasma collection operations. You will manage audits, documentation, training, product release, and regulatory readiness, with authority to stop production or shipments if donor or product safety is at risk.

You’ll collaborate with the Center Manager, oversee CLIA testing, investigations, root-cause analysis, and certification tracking while driving continuous improvement and compliance with FDA/EU cGMP standards.