Quality Assurance Lead - Center Operations & Compliance

CSL Vifor; Portage (MI); 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, manage the QC program, and drive continuous improvement within a regulated plasma environment. The role requires strong leadership, GMP knowledge, and active participation in audits and CAPA processes.

The successful candidate will lead a team, ensure compliance with SOPs, and collaborate with HR and management to maintain a safe, efficient quality system across the site.

Qualifications

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

Responsibilities

• Ensure center is inspection ready by managing SOPs and the quality system; report state of quality to management.
• Manage site Quality Control program including calibrations, sampling, KPIs, and trend analysis.
• Lead and develop direct reports, recruit and conduct performance reviews; take corrective actions up to termination.
• Develop programs to streamline center processes for improved service, yields and results while staying compliant.
• Lead audits and coordinate CAPA; ensure timely closure of audit findings and documentation.

Skills

Quality leadership

GMP knowledge

Regulatory awareness

Auditing

Team leadership

Education

Bachelor's degree in life sciences

Tools

CAPA system

Quality management software

Job description

CSL Vifor is seeking a Quality Assurance leader to ensure the center remains inspection ready, manage the QC program, and drive continuous improvement within a regulated plasma environment. The role requires strong leadership, GMP knowledge, and active participation in audits and CAPA processes.

The successful candidate will lead a team, ensure compliance with SOPs, and collaborate with HR and management to maintain a safe, efficient quality system across the site.