Quality Assurance Lead - Site Standards & Audits

CSL; Kansas City (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL is seeking a Quality Assurance leader to ensure the center remains inspection ready by enforcing SOPs, quality systems, and regulatory compliance. This role oversees the QA program, staff development, audits, and CAPA remediation to sustain high standards across plasma operations.

Responsibilities include leading quality investigations, coordinating corrective actions, and maintaining safe, compliant processes.

Qualifications

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

Responsibilities

• Ensure center is inspection ready by enforcing SOPs and quality systems.
• Manage site Quality Control program including calibrations, sampling, KPIs, and trend analysis.
• Lead and develop staff; recruit, review performance, and take corrective actions.
• Collaborate to streamline processes to improve service, yields and financial results.
• Lead audits with suppliers, customers and regulators, coordinating CAPA and closure.
• Maintain compliant and safe workplace; enforce HSE/OSHA policies.
• Ensure HR compliance and fair treatment of employees.
• Notify senior management for events impacting safety or quality.
• Investigate deviations; determine root cause and effectiveness of corrective actions.

Skills

Leadership experience

Quality management

Regulatory compliance

GMP knowledge

Education

Bachelor degree in scientific discipline/life sciences or related discipline

Job description

CSL is seeking a Quality Assurance leader to ensure the center remains inspection ready by enforcing SOPs, quality systems, and regulatory compliance. This role oversees the QA program, staff development, audits, and CAPA remediation to sustain high standards across plasma operations.

Responsibilities include leading quality investigations, coordinating corrective actions, and maintaining safe, compliant processes.