Senior QC Project Lead – Ig Expansion

CSL; Kankakee (IL); On-site; USD 154,000 - 193,000; Full time

Job summary

CSL Behring is expanding its IgG manufacturing capacity at the Kankakee site (M7/8). The Associate Director, Quality Control will lead QC activities, ensure cGMP compliance, and partner with Regulatory Affairs and Manufacturing to deliver a robust, compliant QC laboratory fit to the expansion.

The role requires expert oversight of change control, analytics, and validation across the project lifecycle. The position reports to Senior Director, Project Quality and directs QC Analysts and QC Sample

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Extensive experience in microbiological/biochemical analytics in GMP environment.
• Laboratory management and operations optimization experience.

Responsibilities

• Provide strategic leadership and governance for QC activities for M7/8 site expansion.
• Identify and mitigate project risks affecting QC deliverables and timelines.
• Lead QC activities for facility design reviews, equipment selection and workflow optimization.
• Ensure readiness of QC activities including testing, qualification runs, and PPQ activities.
• Develop and execute operational readiness plans, staffing and training.

Skills

Quality oversight

Project leadership

Regulatory compliance

cGMP knowledge

Analytical testing

Laboratory management

Change control

Risk assessment

Cross-functional collaboration

Lean Six Sigma

Education

Bachelor’s degree in biology/chemistry

Advanced degree preferred

Job description

CSL Behring is expanding its IgG manufacturing capacity at the Kankakee site (M7/8). The Associate Director, Quality Control will lead QC activities, ensure cGMP compliance, and partner with Regulatory Affairs and Manufacturing to deliver a robust, compliant QC laboratory fit to the expansion.

The role requires expert oversight of change control, analytics, and validation across the project lifecycle. The position reports to Senior Director, Project Quality and directs QC Analysts and QC Sample