Quality Systems Manager, Plasma Center
Overview
Own the quality management system at a plasma donor center, ensuring compliance and continuous improvement at scale. Lead audits, CAPA, and regulatory alignment across state and federal requirements. Collaborate with center leadership to maintain product quality, donor safety, and donor suitability. Drive training, SOP implementation, and root-cause analysis to elevate center performance.
What You'll Do10
- 1Build and maintain the center's quality management system and drive continuous improvement across processes
- 2Lead internal and external audits, oversee corrective and preventive actions, and monitor effectiveness
- 3Design and implement SOPs for quality control and regulatory compliance
- 4Collaborate with Center Manager to ensure donor safety, product quality, and donor suitability
- 5Oversee staff training, competency assessments, and performance management to ensure quality standards
- 6Investigate deviations, perform root-cause analysis, and manage CAPA tracking and closure
- 7Prepare quality analysis reports, communicate status updates, and manage action items in monthly Quality Meetings
- 8Review donor testing, adverse events, and regulatory documentation for accuracy and compliance
- 9Manage documentation control, facility conditions, and supply quality to support regulatory release
- 10Lead projects and initiatives to improve quality and training systems at the donor center
Requirements5
- 1Bachelor of Science or equivalent
- 2Typically 2-5 years of related experience in a medical and/or cGMP regulated environment
- 3Experience with plasma or whole blood
- 4Proficiency in FDA regulations and quality management principles
- 5Ability to travel as needed
Salary Insight
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Location
Required Skills
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