Quality Assurance Lead — GMP, CAPA & Compliance

CSL; Dover (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL in Delaware seeks a QA Manager to oversee the site quality program, ensure inspection readiness, manage CAPA and audits, and drive continuous improvement within GMP and regulatory standards.

You will lead a team, develop procedures, monitor KPIs, and report to quality management, while maintaining compliance and safe operations. This role focuses on safeguarding product quality and regulatory adherence across the center.

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 adhering to SOPs and quality systems.
• Manage site Quality Control program including calibrations, KPIs, and trend analysis.
• Lead and develop QA staff, recruit, conduct reviews and corrective actions.
• Collaborate to streamline center processes for better service and yields.
• Lead audits with suppliers, customers and regulators and close findings.

Skills

Quality leadership

GMP knowledge

Regulatory compliance

Audit experience

Education

Bachelor's degree in life sciences

Job description

CSL in Delaware seeks a QA Manager to oversee the site quality program, ensure inspection readiness, manage CAPA and audits, and drive continuous improvement within GMP and regulatory standards.

You will lead a team, develop procedures, monitor KPIs, and report to quality management, while maintaining compliance and safe operations. This role focuses on safeguarding product quality and regulatory adherence across the center.