Senior Quality Assurance Lead - GMP Compliance & Audits

CSL; Rialto (CA); On-site; USD 80,000 - 112,000; Full time

Job summary

CSL in Rialto, CA is seeking a Quality Assurance leader to ensure the center is inspection-ready by enforcing SOPs, the quality system, and regulatory compliance. You will oversee the Quality Control program, KPIs, trend analysis, root-cause evaluation, and CAPA activities to improve product yield and donor services.

You will recruit, coach and develop staff, lead audits, drive corrective actions, and ensure adherence to GMP, HSE and HR policies, collaborating with management to sustain a

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 enforcing SOPs, quality systems and compliance, preparing reports to management.
• Manage site Quality Control program including calibrations, KPI monitoring, KPI trending, and CAPA/change management.
• Lead and develop staff to perform QA roles, recruit, hire, conduct performance reviews and enforce corrective actions up to termination.
• Participate with management to streamline center processes for better service, product yields and financial results while maintaining compliance and quality.
• Lead center audits and CAPA remediation, coordinate findings and ensure timely closure using quality tools.
• Maintain safe, compliant operations with HR, HSE/OSH policies and routine internal audits.
• Adhere to regulatory policies and ensure confidentiality of personnel/donor/center information.
• Lead investigations into deviations, monitor CAPAs and effectiveness checks.

Skills

Quality Assurance

Regulatory Knowledge

Leadership/Supervisory Experience

GMP/GLP Knowledge

Education

Bachelor degree in scientific discipline/life sciences or related discipline

Job description

CSL in Rialto, CA is seeking a Quality Assurance leader to ensure the center is inspection-ready by enforcing SOPs, the quality system, and regulatory compliance. You will oversee the Quality Control program, KPIs, trend analysis, root-cause evaluation, and CAPA activities to improve product yield and donor services.

You will recruit, coach and develop staff, lead audits, drive corrective actions, and ensure adherence to GMP, HSE and HR policies, collaborating with management to sustain a