Center Quality Manager

Independence 445, Independence, MO , USA

We’re growing fast. Octapharma Plasma is creating learning and career development opportunities, especially at donation centers. If you love learning, enjoy people, and have a heart to help, we encourage you to join us.

• 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).
• Report 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.
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• Execute QA policies and procedures to comply with regulatory requirements.
• Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
• Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
• Ensure QC checks and validation activities are performed in accordance with SOP.
• Ensure equipment maintenance and calibration documentation comply with SOPs.
• Ensure proficiency surveys and CLIA‑required competency assessments are performed in accordance with the required time frames defined in SOP.
• Prepare agenda and lead monthly QA meetings to discuss SOP changes and regulatory requirements; documented minutes are communicated to all donor center staff.
• Serve as Designated QA trainer.
• Prepare for and lead internal and external audits and inspections.
• 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 investigation of trends from failures in procedure execution.

• B.S. degree preferred; other combinations of education and experience may be considered.
• One year experience in a Quality Assurance role required.
• Demonstrated knowledge of FDA, EMA, ISO, and other regulatory standards applicable to plasma collection and handling.
• Experience with quality management systems (QMS) and quality control processes preferred.
• Strong leadership and communication skills; ability to work effectively with cross‑functional teams required.
• Detail‑oriented with excellent problem‑solving and analytical skills required.
• Proficiency in office software.
• Ability to work day and evening hours, weekends, holidays, and extended shifts.

• Formal training
• Medical, dental, and vision insurance plans
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition reimbursement
• Employee assistance program (EAP)
• Wellness program
• Paid time off
• Personal time

Octapharma Plasma, Inc. collects plasma to create life‑saving medicines for patients worldwide. With donation centers and team members throughout the U.S., we are growing at an impressive pace, making a meaningful difference in the lives we touch.

Equal Opportunity Employer. The employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, review the Know Your Rights notice from the Department of Labor.