Quality Assurance Lead – Center Operations & Compliance

CSL; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

CSL seeks a seasoned QA leader in Philadelphia to ensure the center is inspection ready at all times by managing SOPs, quality systems, GMP compliance, and ongoing self-inspection learnings. You will prepare regular quality reports for center, area and corporate management, and drive remediation of non-conformities.

This role leads the QA staff, champions CAPA processes, audits suppliers and regulators, and collaborates with HR and operations to sustain a safe, compliant workplace.

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 SOPs and quality system adherence to GMP standards.
• Manage site Quality Control program including calibrations, KPI monitoring, trend analysis, and CAPA.
• Lead QA staff, develop competencies, conduct reviews, and implement corrective actions up to termination.
• Collaborate with management to streamline center processes for improved customer/donor service and output.
• Lead audits with suppliers, customers, and regulators; coordinate remediation and timely closure of findings.

Skills

Leadership

Quality assurance

Regulatory knowledge

GMP understanding

Education

Bachelor's degree in life sciences

Job description

CSL seeks a seasoned QA leader in Philadelphia to ensure the center is inspection ready at all times by managing SOPs, quality systems, GMP compliance, and ongoing self-inspection learnings. You will prepare regular quality reports for center, area and corporate management, and drive remediation of non-conformities.

This role leads the QA staff, champions CAPA processes, audits suppliers and regulators, and collaborates with HR and operations to sustain a safe, compliant workplace.