Senior Lead, External Quality & Supplier Qualification

CSL; Bradley (IL); On-site; USD 172,000 - 203,000; Full time

Job summary

CSL Behring Kankakee is expanding Ig production and building a new fill-finish facility. The role provides Quality oversight for external supplier activities and leads a small audit team to ensure GMP compliance across materials, services, and distributors.

The candidate will manage supplier quality agreements, participate in deviation investigations, and support change controls, audits, and budget planning within a global matrix organization.

Qualifications

• Bachelor’s degree in a relevant scientific discipline; advanced degree preferred.
• 10+ years in a GxP pharma environment with leadership experience.
• Strong regulatory knowledge (FDA, PIC/s, EU, TGA, etc.).

Responsibilities

• Lead supplier quality audits and manage the qualification program.
• Serve as primary site interface for supplier quality matters.
• Collaborate with Global Sourcing and external quality teams.
• Support deviation investigations and change control processes.
• Oversee supplier quality agreements and related approvals.
• Assist in budgeting and forecasting for external audits.
• Communicate quality policies during regulatory audits.

Skills

Quality oversight

Auditing leadership

Regulatory knowledge

GxP experience

Cross-functional collaboration

Education

Bachelor's degree in biology/chemistry

Advanced degree preferred

Job description

CSL Behring Kankakee is expanding Ig production and building a new fill-finish facility. The role provides Quality oversight for external supplier activities and leads a small audit team to ensure GMP compliance across materials, services, and distributors.

The candidate will manage supplier quality agreements, participate in deviation investigations, and support change controls, audits, and budget planning within a global matrix organization.