Quality Assurance Lead, Plasma Center

CSL Vifor; Dover (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL Plasma in Dover, Delaware seeks a Quality Assurance Manager to ensure the center remains inspection-ready by enforcing SOPs, quality systems, self-inspections, CAPA and audit remediation across daily operations.

You will lead and develop QA staff, monitor KPIs and trend data, conduct root-cause analyses, drive corrective actions, and coordinate with regulatory bodies to maintain GMP compliance and high standards for donor safety and product quality.

Qualifications

• Bachelor degree in scientific discipline/life sciences or related discipline.
• 5+ years' experience related to quality and regulatory/plasma industry experience.
• Demonstrated leadership/supervisory experience.
• Knowledge of government and industry regulations.

Responsibilities

• Ensure center is audit-ready by enforcing SOPs, quality system, self-inspection learnings, CAPA and remediation.
• Manage site Quality Control program including calibrations, sampling, KPI tracking, trend analysis and root-cause assessment.
• Lead QA staff development, performance reviews and corrective actions up to termination.
• Coordinate with management to improve center processes for better service, yields and compliance.
• Lead investigations into deviations and ensure timely closure of audit findings.

Skills

Leadership

Regulatory knowledge

Education

Bachelor degree in scientific discipline/life sciences

Job description

CSL Plasma in Dover, Delaware seeks a Quality Assurance Manager to ensure the center remains inspection-ready by enforcing SOPs, quality systems, self-inspections, CAPA and audit remediation across daily operations.

You will lead and develop QA staff, monitor KPIs and trend data, conduct root-cause analyses, drive corrective actions, and coordinate with regulatory bodies to maintain GMP compliance and high standards for donor safety and product quality.