Associate Director, External Supplier Quality & Site Projects

CSL; Chicago (IL); Vor Ort; USD 172.000 - 203.000; Vollzeit

Zusammenfassung

CSL Behring is expanding its M7/8 site at Kankakee to incorporate Ig production. This role provides Quality oversight for external supplier activities and leads a small audit team to ensure compliance with FDA, PIC/S, and other regulatory requirements across raw materials, services, and distributors.

You will act as the primary site interface for supplier quality matters, drive audit programs, participate in change controls, and collaborate with Global Sourcing to maintain robust supplier

Qualifikationen

• Bachelor’s degree in biology, microbiology, chemistry, or related field; 10+ years in a GxP/pharma environment.
• Minimum 3 years leading a team.
• Strong knowledge of FDA, PIC/S, EU regulations and other relevant authorities.

Aufgaben

• Provide quality oversight for external supplier activities related to the M7/8 site expansion at CSL Behring Kankakee.
• Lead audits of suppliers and service providers to ensure regulatory compliance.
• Collaborate with global sourcing and external quality functions to manage supplier qualification and auditing programs.
• Represent External Supplier Quality during regulatory audits.
• Support budgeting and forecasting for external audits.

Kenntnisse

Auditing

Quality oversight

Team leadership

Regulatory knowledge

Cross-functional collaboration

English fluent

Ausbildung

Bachelor’s degree in biology/chemistry/microbiology or related field

Advanced degree preferred

Jobbeschreibung

CSL Behring is expanding its M7/8 site at Kankakee to incorporate Ig production. This role provides Quality oversight for external supplier activities and leads a small audit team to ensure compliance with FDA, PIC/S, and other regulatory requirements across raw materials, services, and distributors.

You will act as the primary site interface for supplier quality matters, drive audit programs, participate in change controls, and collaborate with Global Sourcing to maintain robust supplier