Center Quality Manager 1

Center Quality Manager 1 – Octapharma Plasma, Inc.

We're growing fast and offer strong learning and career development opportunities across our donation centers. This role is for someone who loves to learn, enjoys working with people, and has a heart to help donors and patients.

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.
• Report critical incidents and negative trends to the 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 quality control processes, including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for all product shipments and related documents to ensure shipments meet customer specifications.
• Execute QA policies and procedures to comply with regulatory requirements.
• Ensure QC checks and validation activities are performed in accordance with SOPs.
• Prepare for and lead internal and external audits and inspections; develop and implement audit responses with 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 be responsible for training Quality backup staff and Plasma Center Quality Manager I.
• Develop and deliver training programs for staff on quality topics, including GMP, SOPs, and regulatory compliance.
• Perform proficiency surveys and CLIA-required competency assessments within required SOP timeframes.
• Ensure equipment maintenance and calibration documentation comply with SOPs.
• Perform root cause analysis, implement corrective / preventive actions, and conduct effectiveness checks for systemic issues.
• Promote and improve the effectiveness of the quality systems in the plasma center by investigating trends from failures in procedures.
• Support continuous improvement initiatives and monitor the effectiveness of changes.
• Prepare agendas and lead monthly Quality Assurance Meetings to discuss SOP changes and regulatory requirements, ensuring minutes are communicated to all donor center staff.
• Participate in the selection process for the Quality Assurance Back-up role and provide direction to Back-up staff to complete quality tasks within required timeframes.
• Perform other duties as assigned.

Qualifications

Physical Requirements

Benefits

Interested? Learn more online and apply now at : octapharmaplasma.com

Note : This posting contains core job information and reflects the responsibilities and requirements of the Center Quality Manager 1 role.

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