Quality Assurance Lead - GMP, Audits & Compliance

CSL Vifor; Topeka (KS); On-site; USD 90,000 - 120,000; Full time

Job summary

CSL Vifor is seeking a Quality Assurance leader to ensure the center remains inspection-ready through SOP adherence, quality system implementation, and proactive remediation of non-conformities.

The role requires 5+ years in quality/regulatory work within plasma or related industries, with demonstrated leadership and strong knowledge of applicable regulations. You will guide audits, CAPA, and continuous improvement across the site.

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, quality system and non-conformity remediation.
• Manage site Quality Control program including calibrations, sampling, KPIs, trending and root-cause analysis.
• Lead and develop staff to ensure high competency in QA roles and conduct performance reviews.
• Lead audits with suppliers, customers and regulators and coordinate CAPA closures.
• Maintain safe, compliant operations and HR compliance across the center.
• Lead investigations into deviations and implement corrective actions.

Skills

Leadership experience

Regulatory knowledge

Quality systems

Education

Bachelor degree in scientific discipline

Job description

CSL Vifor is seeking a Quality Assurance leader to ensure the center remains inspection-ready through SOP adherence, quality system implementation, and proactive remediation of non-conformities.

The role requires 5+ years in quality/regulatory work within plasma or related industries, with demonstrated leadership and strong knowledge of applicable regulations. You will guide audits, CAPA, and continuous improvement across the site.