QC Program Lead for Ig Expansion & Site Startup

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

Job summary

CSL Behring seeks an Associate Director, Quality Control to lead QC activities for the M7/M8 Ig expansion at the CSL Behring Kankakee site, supporting startup, qualification, validation, and readiness for commercial manufacturing.

You will build a high-performing QC organization, ensure cGMP compliance, manage change control for analytical methods, and collaborate across Regulatory, Manufacturing, and Supply Chain to deliver milestones.

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry, or related field.
• 10+ years in microbiological/biochemical analytics in a pharmaceutical/medicinal GMP environment.
• Significant experience in laboratory management, including operations optimization.
• Strong experience supporting regulatory inspections and customer audits.
• Extensive knowledge of analytical instruments and GxP regulations.
• Management/demonstrated leadership experience.
• Experience within a global matrix organization.
• Six sigma, lean, and/or variability reduction.
• Ability to work in a fast-paced environment and balance future needs with immediate pressures.

Responsibilities

• Provide strategic leadership and governance for all M7/8 QC activities supporting the successful delivery, startup, qualification, validation, and operational readiness of the new IgG manufacturing facility.
• Identify, assess, and mitigate project risks impacting QC deliverables, laboratory readiness, testing capacity, method implementation, and qualification timelines, escalating critical issues to senior leadership as appropriate.
• Lead QC activities supporting facility design reviews, user requirements, laboratory fit-out, equipment selection, and workflow optimization in consultation with site Operational QC. Develop and execute the overall project strategy, ensuring alignment with project objectives, regulatory expectations, cGMP requirements, site priorities, and CSL quality standards.
• Ensure timely readiness of QC activities including utilities and environmental monitoring sampling, testing for project qualification activities, assay tech transfer and validation, equipment purchases and qualification, establishment of new raw materials, and testing support of qualification runs. to support engineering runs, process validation, PPQ activities, and commercial manufacturing.
• Develop and execute comprehensive operational readiness plans, including staffing, training, procedures, equipment qualification, and inventory management.
• Manage QC activities by project timelines, budgets, resources, and risk mitigation plans to support successful project delivery.
• Review and assess existing QC policies and procedures for successful execution of M 7/8. Perform gap assessment and suggest improvements in existing and future procedures and policies.
• Establish and maintain a comprehensive QC project roadmap, ensuring milestones, resources, budgets, risks, and deliverables are proactively managed and aligned with overall project timelines.
• Provide strategic oversight of change control activities related to analytical methods, specifications, testing strategies, laboratory systems, equipment, and quality processes, ensuring timely implementation to meet project objectives.
• Build and maintain strong relationships with internal and external stakeholders, including regulatory authorities, equipment suppliers, testing laboratories, consultants, and project partners, as required.

Skills

Leadership

Quality systems

Regulatory inspections

Project governance

cGMP knowledge

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

CSL Behring seeks an Associate Director, Quality Control to lead QC activities for the M7/M8 Ig expansion at the CSL Behring Kankakee site, supporting startup, qualification, validation, and readiness for commercial manufacturing.

You will build a high-performing QC organization, ensure cGMP compliance, manage change control for analytical methods, and collaborate across Regulatory, Manufacturing, and Supply Chain to deliver milestones.