Associate Director, Project Quality - QC

The growing demand for expanding production lined requires an expansion of CSL's manufacturing capacity. To support this growth, immunoglobulin (Ig) production activities-from plasma thawing through sterile filling-will be incorporated into the new Building under construction at the CSL Kankakee (KAN) site to accommodate Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8.

This role will provide Quality oversight for change control activities associated with the M 7/8 Site Expansion Project at the CSL Behring Kankakee site.

The Associate Director, Quality Control (QC) will provide strategic and operational leadership for Quality Control activities supporting the M7/M8 Immunoglobulin (Ig) Expansion Project. This role is accountable for building and leading a high-performing QC organization that ensures successful project execution, regulatory compliance, operational readiness, method lifecycle management, laboratory qualification, and commercialization support for expanded manufacturing capacity.

The individual will serve as a key member of the Project Quality leadership team and cross-functional project governance structure. Forming key partnerships with the Site QC and Operational Quality team to ensure delivery of the robust and complaint operational QC laboratory fit to the expansion.

Other partnerships within Manufacturing, QC Technical Services , Engineering, Technical Operations, Validation, Global Quality, Regulatory Affairs, and Supply Chain to deliver project milestones while maintaining compliance with cGMP, regulatory requirements, and company quality standards.

Reports To: Senior Director, Project Quality

Direct Reports: QC Analysts, QC Sample Management Associate, QCAT Associates

Responsibilities:

1. 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.

2. 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.

3. 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.

4. 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.

5. Develop and execute comprehensive operational readiness plans, including staffing, training, procedures, equipment qualification, and inventory management.

6. Manage QC activities by project timelines, budgets, resources, and risk mitigation plans to support successful project delivery.

7. 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.

8. Establish and maintain a comprehensive QC project roadmap, ensuring milestones, resources, budgets, risks, and deliverables are proactively managed and aligned with overall project timelines

9. 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.

10. Build and maintain strong relationships with internal and external stakeholders, including regulatory authorities, equipment suppliers, testing laboratories, consultants, and project partners, as required.

Qualifications:

• Bachelor's degree in relevant scientific discipline (biology, microbiology,chemistry, etc.); advanced degree preferred

• 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…