Quality Assurance Lead — Center Operations

CSL; Auburn (AL); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL seeks a Quality Leader to ensure inspection readiness and uphold GMP/compliance in a plasma center. You will enforce SOPs, manage the quality system, and drive improvements across operations.

You will lead QA staff, oversee CAPA investigations, and coordinate internal and external audits while maintaining safety and HR compliance. Strong regulatory knowledge and leadership are essential.

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 “inspection ready” by managing adherence to SOPs and the quality system, utilizing quality principles and remediation.
• Manage site Quality Control program including calibrations, sampling, KPIs, trend analysis, and CAPA.
• Lead and develop direct reports, recruit, hire, conduct performance reviews and implement corrective actions up to termination.
• Participate with management to streamline center processes improving customer/donor service, product yields and financial results while maintaining compliance.
• Lead quality representations for audits, coordinate remediation (CAPA) and ensure timely closure of findings.
• Maintain a safe, clean work environment and ensure availability of forms, supplies, and compliance with HSE and OSHA policies.

Skills

Leadership

Quality management

Regulatory knowledge

Staff development

Education

Bachelor's degree in scientific discipline/life sciences

Job description

CSL seeks a Quality Leader to ensure inspection readiness and uphold GMP/compliance in a plasma center. You will enforce SOPs, manage the quality system, and drive improvements across operations.

You will lead QA staff, oversee CAPA investigations, and coordinate internal and external audits while maintaining safety and HR compliance. Strong regulatory knowledge and leadership are essential.