Associate Director, QC - Ig Expansion Lead

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

Job summary

CSL Behring Behring Kankakee site is expanding Ig production with the M7/M8 project. An Associate Director of Quality Control will provide strategic leadership, ensuring QC readiness, regulatory alignment, and successful project execution for the expanded facility.

The role leads a high-performing QC team, partners with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to meet milestones while maintaining cGMP compliance and quality integrity.

Qualifications

• Bachelor’s degree in relevant scientific discipline (biology, microbiology, chemistry, etc.).
• 10+ years' experience in microbiological/biological, chemical or biochemical analytics in a pharma GMP environment.
• Significant experience in laboratory management and operations optimization.
• Strong experience supporting regulatory inspections and customer audits.
• Extensive knowledge of analytical instruments and GxP regulations.
• Management/leadership experience.
• Experience within a global matrix organization.
• Six sigma/lean/variability reduction experience.
• Ability to work in a fast-paced environment with competing priorities.

Responsibilities

• Provide strategic leadership and governance for all QC activities supporting the Ig facility startup, qualification, validation, and operational readiness.
• Identify, assess, and mitigate project risks impacting QC deliverables and testing capacity.
• Lead QC activities for facility design reviews, laboratory fit-out, equipment selection, and workflow optimization.
• Ensure timely readiness of QC activities including utilities, environmental monitoring, assay transfer and validation, and PPQ support.
• Develop and execute operational readiness plans including staffing, training, procedures, and inventory management.
• Manage QC activities by project timelines, budgets, and risk plans to support delivery.
• Review QC policies and procedures; perform gap analyses and improvements.
• Establish and maintain a comprehensive QC project roadmap with milestones and resources.
• Provide strategic oversight of change control related to analytical methods and quality processes.
• Build strong relationships with regulatory authorities, suppliers, labs, consultants, and partners.

Skills

Leadership

Regulatory inspections

Analytical instruments knowledge

GxP regulations knowledge

Strategic thinking

Cross-functional collaboration

Education

Bachelor’s degree in biology/chemistry

Advanced degree preferred

Tools

Analytical instruments

Job description

CSL Behring Behring Kankakee site is expanding Ig production with the M7/M8 project. An Associate Director of Quality Control will provide strategic leadership, ensuring QC readiness, regulatory alignment, and successful project execution for the expanded facility.

The role leads a high-performing QC team, partners with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to meet milestones while maintaining cGMP compliance and quality integrity.