Center Quality Manager 1

Center Quality Manager 1

Description

Job Summary

This role serves as a member of the plasma center management team. The position will ensure all activities and processes related to plasma collection, donor eligibility, and product quality comply with regulatory requirements, industry standards, and company policies.

This is What You’ll Do

• Operate independent of plasma center Operations to ensure compliance with all applicable federal, state, and local regulations, as well as industry standards (e.g., FDA, EMA).
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• Reports critical incidents and negative trends to plasma center Operations team and Regional Quality Director.
• Collaborate with the plasma center Operations team to ensure product quality and donor safety.
• Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.
• Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
• Execute QA policies and procedures to comply with regulatory requirements.
• Quality Control (QC) checks and validation activities are performed in accordance with SOP.
• Prepare for and lead internal and external audits and inspections.
• Develop and implement audit responses ensuring timely completion and adherence to quality standards.
• Maintain audit records and follow up on audit findings and corrective actions.
• Serve as Designated QA Trainer and responsible for training Quality backup staff and Plasma Center Quality Manager I.
• Develop and deliver training programs for staff on quality-related topics, including GMP (Good Manufacturing Practice), SOPs (Standard Operating Procedures), and regulatory compliance.
• Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.
• Equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).
• Perform root cause analysis, implement corrective/preventive actions, and conduct effectiveness checks for systemic issues.
• Continuously assess, promote, and improve the effectiveness of the quality systems in the plasma center through the investigation of trends resulting from failures in the execution of procedures.
• Support the implementation of continuous improvement initiatives.
• Monitor the effectiveness of implemented changes and adjust strategies as necessary.
• Prepare agenda and lead monthly Quality Assurance Meeting to discuss SOP changes and regulatory requirements are conducted, documented and m