Quality Control Leader for Ig Expansion (M7/M8)

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

Job summary

CSL Vifor is expanding Ig production at the Kankakee site and seeks an Associate Director of Quality Control to lead the M7/8 QC organization. This role provides strategic and operational leadership for QC activities, ensuring regulatory compliance and readiness for the Ig expansion project.

The role collaborates with Site QC, Regulatory Affairs, and manufacturing teams to deliver robust QC support, from design reviews to qualification, while maintaining cGMP standards and project milestones.

Qualifications

• Bachelor’s degree in biology, chemistry, or related scientific field; advanced degree preferred.
• Extensive experience in GMP QA/QC environments and regulatory inspections.

Responsibilities

• Provide strategic leadership and governance for M7/8 QC activities to enable delivery, startup, qualification, and readiness of the IgG facility.
• Identify, assess, and mitigate risks affecting QC deliverables, lab readiness, testing capacity, methods, and qualification timelines.
• Lead QC activities for facility design reviews, user requirements, lab fit-out, equipment selection, and workflow optimization, in coordination with site QC.
• Ensure readiness of utilities, environmental monitoring, assay transfer/validation, equipment qualification, and raw material testing for qualification runs and PPQ.
• Develop and execute operational readiness plans: staffing, training, procedures, equipment qualification, and inventory management.
• Manage QC activities by timelines, budgets, resources, and risk mitigation to support project delivery.
• Review policies; perform gap assessments and implement improvements to procedures and policies for M7/8.
• Establish a comprehensive QC project roadmap with milestones, resources, budgets, risks, and deliverables.
• Provide strategic oversight of change control for analytical methods, specifications, testing strategies, laboratory systems and quality processes.
• Build strong relationships with regulators, suppliers, testing laboratories, consultants, and project partners.

Skills

Leadership

Strategic planning

Risk management

Regulatory experience

Quality oversight

Stakeholder management

Education

Bachelor's degree in relevant scientific discipline

Advanced degree preferred

Job description

CSL Vifor is expanding Ig production at the Kankakee site and seeks an Associate Director of Quality Control to lead the M7/8 QC organization. This role provides strategic and operational leadership for QC activities, ensuring regulatory compliance and readiness for the Ig expansion project.

The role collaborates with Site QC, Regulatory Affairs, and manufacturing teams to deliver robust QC support, from design reviews to qualification, while maintaining cGMP standards and project milestones.