Center Quality Manager

Job Summary

Are you a quality-driven leader with a passion for compliance and operational excellence? Join our team as a Quality Assurance Manager and take ownership of ensuring that plasma collection operations meet the highest standards of safety, accuracy, and regulatory compliance. In this role, you’ll lead quality initiatives, manage audits, and empower your team to uphold the integrity of life-saving plasma products.

As the Quality Assurance Manager, you’ll collaborate with the Center Manager and oversee all quality-related activities, including documentation, training, product release, and regulatory readiness. You’ll be a key decision-maker with the authority to stop production or shipments when necessary to protect donor safety and product quality.

What You'll Do:

• 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.

Qualifications:

• Bachelor’s degree in healthcare, life sciences, or a 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.
• Proficiency in Microsoft Office and familiarity with data entry and recordkeeping systems.
• Ability to lead teams and manage multiple priorities in a fast-paced environment.
• Comfortable working in regulated settings with exposure to bloodborne pathogens and cold storage areas.
• Willingness to travel to other plasma centers and Kedrion locations as needed.