US Quality Manager — GMP & GDP Compliance

CSL Plasma; Kankakee (IL); On-site; USD 106,000 - 125,000; Full time

Job summary

CSL Plasma in the United States seeks a Quality Manager for the USA to support QMS operations and serve as back‑up Local Quality Officer for CSL Behring affiliate operations. The role involves ensuring GDP compliance, timely PTC resolution, and quality support across warehousing, logistics, and customer service.

The position requires a bachelor’s degree in a relevant field and at least 5 years of GMP quality experience in pharma manufacturing.

Qualifications

• Bachelor's degree in a relevant business or science discipline.
• Minimum 5 years of GMP quality or systems experience in pharmaceutical manufacturing.
• Experience with GDP systems implementation and utilization is desirable.
• Strong collaboration and communication skills with analytical mindset.

Responsibilities

• Support Quality System operations and back-up Local Quality Officer for US affiliate operations.
• Support Product Technical Complaint (PTC) process and ensure timely resolution.
• Provide quality support for Warehousing, Logistics, and Customer Service GDP activities.
• Ensure timely release for domestic products and US-manufactured exports.
• Manage deviations and drive corrective actions to limit market impact.
• Serve as real-time interface for US Commercial Ops, Global Logistics and Sites.
• Support recalls and counterfeit investigations; liaise with Global affiliates.
• Collaborate with Global Supplier Quality on audits and quality agreements.
• Create/update Local and Global SOPs and QA procedures.
• Review local GMP/GDP regulations and assess impact on practices.
• Drive continuous improvement in global and local quality operations.
• Generate Lot Distribution Reports per FDA requirements.
• Maintain inspection readiness and plan regulatory drills.
• Limited travel may be required.

Skills

Quality management

GMP experience

Regulatory compliance

SAP experience

Education

Bachelor's degree in business or science

Tools

SAP

Job description

CSL Plasma in the United States seeks a Quality Manager for the USA to support QMS operations and serve as back‑up Local Quality Officer for CSL Behring affiliate operations. The role involves ensuring GDP compliance, timely PTC resolution, and quality support across warehousing, logistics, and customer service.

The position requires a bachelor’s degree in a relevant field and at least 5 years of GMP quality experience in pharma manufacturing.