Quality Assurance Lead — Center Operations & Compliance

CSL; Portage (MI); On-site; USD 110,000 - 150,000; Full time

Job summary

CSL in Portage, MI seeks a Quality Assurance Leader to ensure the center stays inspection-ready by enforcing SOPs, quality systems, and regulatory standards. You will drive continuous improvement and lead a team focused on quality across operations.

The role involves managing the site Quality Control program, coordinating audits, CAPA, and root-cause analysis while ensuring safety, HR compliance, and regulatory alignment for plasma quality products.

Qualifications

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

Responsibilities

• Ensure center is inspection ready by SOPs and quality systems.
• Manage QC program including calibrations, KPI tracking, trend analysis and KPI reporting.
• Lead and develop QA staff, hire, review performance and take corrective actions.
• Coordinate audits and CAPA remediation; ensure timely closure of findings.
• Maintain safe, compliant work environment and HR compliance and policies.
• Investigate deviations and verify effectiveness of CAPA actions.

Skills

Leadership

Quality management

Regulatory compliance knowledge

SOP adherence

Communication

Education

Bachelor degree in scientific discipline/life sciences

Job description

CSL in Portage, MI seeks a Quality Assurance Leader to ensure the center stays inspection-ready by enforcing SOPs, quality systems, and regulatory standards. You will drive continuous improvement and lead a team focused on quality across operations.

The role involves managing the site Quality Control program, coordinating audits, CAPA, and root-cause analysis while ensuring safety, HR compliance, and regulatory alignment for plasma quality products.