Associate Director, External Supplier Quality & Audit Lead

CSL; Illinois; Vor Ort; USD 172.000 - 203.000; Vollzeit

Zusammenfassung

CSL Behring Kankakee site expansion seeks a Quality Oversight leader to manage external supplier quality for the M7/8 project. You will lead audits, ensure regulatory compliance, and drive end-to-end quality processes for raw materials, services, and distributors.

The role requires senior GxP experience, strong leadership, and collaboration across global teams; you will interface with site operations and regulatory bodies to support safe, compliant manufacturing.

Qualifikationen

• 10+ years in a GxP environment within the pharmaceutical industry.
• Minimum 3 years leading a team.
• Strong regulatory knowledge (FDA, PIC/s, EU, TGA, Health Canada).
• Experience auditing internal and external suppliers.

Aufgaben

• Implement strategic goals established by functional leadership.
• Collaborate to manage supplier qualification auditing program and auditor qualification standards.
• Establish risk management tools for supplier and raw material monitoring.
• Serve as primary M7/8 site interface for supplier quality issues.
• Attend deviation review meetings and assist deviation investigations.
• Participate in change control processes.
• Perform quality systems audits of suppliers, service providers, and distributors.
• May perform M7/8 project site audits as requested.
• Represent External Supplier Quality policies during regulatory audits.

Kenntnisse

Auditing

GxP knowledge

Quality systems auditing

Leadership

Regulatory knowledge

Cross-functional collaboration

Ausbildung

Bachelor's degree in biology/chemistry/microbiology

Advanced degree preferred

Jobbeschreibung

CSL Behring Kankakee site expansion seeks a Quality Oversight leader to manage external supplier quality for the M7/8 project. You will lead audits, ensure regulatory compliance, and drive end-to-end quality processes for raw materials, services, and distributors.

The role requires senior GxP experience, strong leadership, and collaboration across global teams; you will interface with site operations and regulatory bodies to support safe, compliant manufacturing.