QC Project Quality Director – Expansion Leader

CSL Plasma Inc.; Kankakee, Northern (IL, KY); Hybrid; USD 154,000 - 193,000; Full time

Job summary

CSL Behring is expanding Ig production at the Kankakee site and seeking an Associate Director of Quality Control to lead the QC organization for the M7/8 site expansion. You will drive strategic oversight of change control, method validation, and laboratory readiness while ensuring compliance with cGMP and global quality standards.

The role involves partnering with site QC, Manufacturing, Regulatory Affairs, and Supply Chain to deliver project milestones, optimize QC operations, and support

Qualifications

• Bachelor's degree in relevant scientific discipline (biology, microbiology, chemistry, etc.).
• 10+ years' experience in microbiological and biological, chemical or 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.
• 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 M7/8. 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

Strategic leadership

Quality oversight

GxP regulations

Cross-functional leadership

Change control

Education

Bachelor's degree in science

Advanced degree preferred

Job description

CSL Behring is expanding Ig production at the Kankakee site and seeking an Associate Director of Quality Control to lead the QC organization for the M7/8 site expansion. You will drive strategic oversight of change control, method validation, and laboratory readiness while ensuring compliance with cGMP and global quality standards.

The role involves partnering with site QC, Manufacturing, Regulatory Affairs, and Supply Chain to deliver project milestones, optimize QC operations, and support