Senior QA Lead: Compliance, Audits & CAPA

CSL Plasma; Salt Lake City (UT); On-site; USD 90,000 - 125,000; Full time

Job summary

CSL Plasma in Salt Lake City is seeking a Quality Assurance leader to ensure the center remains inspection-ready by upholding SOPs, policies and the quality system. You will drive the QA program, monitor KPIs, and lead CAPA initiatives with a focus on patient donor safety and regulatory compliance.

The role requires 5+ years in quality/regulatory within the plasma industry, strong leadership, and deep knowledge of applicable regulations.

Qualifications

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

Responsibilities

• Ensure center is inspection ready at all times by adhering to SOPs, compliance policies and the quality system.
• Manage site Quality Control program including calibrations, KPI monitoring, and trend analysis.
• Lead and develop staff to perform QA roles, conduct performance reviews and drive competency.
• Develop programs to streamline center processes for improved service, yields and compliance.
• Lead audits with suppliers, customers and regulators; coordinate CAPA and closure of findings.

Skills

Quality Management

Leadership

Regulatory Knowledge

GMP

Quality Audits

Education

Bachelor's degree in life sciences

Job description

CSL Plasma in Salt Lake City is seeking a Quality Assurance leader to ensure the center remains inspection-ready by upholding SOPs, policies and the quality system. You will drive the QA program, monitor KPIs, and lead CAPA initiatives with a focus on patient donor safety and regulatory compliance.

The role requires 5+ years in quality/regulatory within the plasma industry, strong leadership, and deep knowledge of applicable regulations.