Quality Validation Lead - GMP Project Oversight + Equity

CSL Vifor; Kankakee (IL); On-site; USD 91,000 - 120,000; Full time

Job summary

CSL Vifor in Illinois is expanding its Ig manufacturing facility to support Privigen and Hizentra production. The role provides quality oversight for Commissioning & Qualification activities, ensuring cGMP compliance across document controls, change management, and audits while collaborating with multiple teams globally.

Ideal candidates have 5+ years in quality/GMP within pharma/biotech, knowledge of FDA/EU guidelines, and experience overseeing GMP-compliant facility qualification.

Qualifications

• 5 years' experience in quality/GMP in pharma/biotech.
• Experience with FDA, EU, and other regulatory guidelines.
• Quality oversight of commissioning and qualification of facilities.
• Strong knowledge of GMP and cGMP processes.

Responsibilities

• Ensure GMP-compliant planning and validation task execution.
• Maintain quality systems and SOPs to ensure cGMP compliance.
• Review/approve standards governing quality systems and processes.
• Support regulatory inspections, audits, and supplier assessments.
• Collaborate across functions to share best practices.
• Provide quality oversight of CAPEX/OPEX project realizations.

Skills

GMP knowledge

Quality oversight

Regulatory compliance

Project quality

Education

Degree in Pharmacy/Biology/Chemistry

Job description

CSL Vifor in Illinois is expanding its Ig manufacturing facility to support Privigen and Hizentra production. The role provides quality oversight for Commissioning & Qualification activities, ensuring cGMP compliance across document controls, change management, and audits while collaborating with multiple teams globally.

Ideal candidates have 5+ years in quality/GMP within pharma/biotech, knowledge of FDA/EU guidelines, and experience overseeing GMP-compliant facility qualification.