Director, QC Project Quality & Validation

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

Job summary

CSL Behring seeks a Senior Director, Project Quality to lead QC activities for the new IgG manufacturing facility. You will govern QC strategy, risk mitigation, and readiness across testing, transfer, and validation while coordinating with regulatory bodies and suppliers.

Responsibilities include ensuring lab readiness, managing budgets and timelines, and driving change control aligned with cGMP requirements. This role requires extensive leadership in a global matrix setting.

Qualifications

• Bachelor's degree in biology, microbiology, chemistry, or related field; advanced degree preferred.
• 10+ years of experience in microbiological/biological/chemical analytics in a pharma GMP environment.
• Significant experience in laboratory management and operations optimization.
• Experience supporting regulatory inspections and customer audits.
• Extensive knowledge of analytical instruments and GxP regulations.
• Leadership and experience in a global matrix organization; Six Sigma/Lean preferred.

Responsibilities

• Provide strategic leadership and governance for all 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, lab readiness, testing capacity, method implementation, and qualification timelines; escalate critical issues as needed.
• Lead QC activities supporting facility design reviews, user requirements, laboratory fit-out, equipment selection, and workflow optimization in consultation with site Operational QC.
• 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; perform gap assessments and implement improvements.
• Establish and maintain a comprehensive QC project roadmap with milestones, budgets, risks, and deliverables.
• Provide strategic oversight of change control activities related to analytical methods, specifications, testing strategies, laboratory systems, equipment, and quality processes.
• Build and maintain relationships with regulators, equipment suppliers, testing laboratories, consultants, and project partners.

Skills

Leadership

Regulatory inspections

GxP regulations

Risk management

Project management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Analytical instruments

Job description

CSL Behring seeks a Senior Director, Project Quality to lead QC activities for the new IgG manufacturing facility. You will govern QC strategy, risk mitigation, and readiness across testing, transfer, and validation while coordinating with regulatory bodies and suppliers.

Responsibilities include ensuring lab readiness, managing budgets and timelines, and driving change control aligned with cGMP requirements. This role requires extensive leadership in a global matrix setting.