Associate Director, QC Leadership - Ig Expansion (M7/M8)

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

Job summary

CSL Behring is expanding IgG manufacturing capacity at the Kankakee site (M7/8) and seeks an Associate Director, Quality Control to lead the QC organization. You will guide change control, laboratory qualification, method lifecycle management, and regulatory readiness to support startup and commercialization for expanded capacity.

The role partners with Site QC, Operational Quality, and cross-functional teams to ensure compliant, robust QC operations, while delivering project milestones and

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry or related field. Advanced degree preferred.
• 10+ years' experience in microbiological/biochemical analytics in a pharmaceutical GMP environment.
• Significant laboratory management experience and operations optimization.
• Experience supporting regulatory inspections and customer audits.
• Extensive knowledge of analytical instruments and GxP regulations.
• Demonstrated leadership and experience in global matrix organizations.

Responsibilities

• Provide strategic leadership and governance for all M7/8 QC activities to ensure startup, qualification, validation, and readiness of the IgG facility.
• Identify, assess, and mitigate project risks impacting QC deliverables and timelines.
• Lead QC activities supporting facility design reviews, equipment selection, and workflow optimization.
• Ensure readiness of QC activities including environmental monitoring, testing, and TPQ activities.
• Develop and execute operational readiness plans including staffing, training, and procedures.
• Manage QC activities by timelines, budgets, resources, and risk mitigation.

Skills

Leadership

Project governance

Change control

Cross-functional collaboration

Regulatory readiness

Education

Bachelor’s degree in relevant scientific discipline

Advanced degree preferred

Job description

CSL Behring is expanding IgG manufacturing capacity at the Kankakee site (M7/8) and seeks an Associate Director, Quality Control to lead the QC organization. You will guide change control, laboratory qualification, method lifecycle management, and regulatory readiness to support startup and commercialization for expanded capacity.

The role partners with Site QC, Operational Quality, and cross-functional teams to ensure compliant, robust QC operations, while delivering project milestones and