Senior Supplier Quality Lead - M7/8 Project

CSL; Kankakee (IL); Presencial; USD 172.000 - 203.000; Jornada completa

Descripción de la vacante

CSL Behring Behring Kankakee site seeks a Quality Oversight lead to manage external supplier audits and ensure compliance with regulatory requirements across the M7/8 expansion project. You will direct audit programs, facilitate deviation investigations, and oversee supplier quality agreements.

The role requires a strong GxP background, extensive regulatory knowledge, and prior leadership experience in a global pharmaceutical environment.

Formación

• Bachelor’s degree in biology, microbiology, chemistry, or related science; advanced degree preferred.
• 10+ years’ experience in a GxP environment within the pharmaceutical industry.
• Minimum 3 years’ experience in leading a team.
• Strong regulatory knowledge across FDA, PIC/S, European regulation, TGA, Health Canada, etc.
• Auditing experience (internal and external) within the industry.

Responsabilidades

• Implement strategic goals established by functional leadership.
• Lead supplier quality auditing program including auditor qualification and audit determinations.
• Establish risk management tools and supplier/material monitoring concepts.
• Serve as primary site interface for supplier quality matters and project scope.
• Oversee supplier quality agreements and related regulatory communications.
• Support budgetary planning and forecasting for external audits.

Conocimientos

GxP experience

Team leadership

Regulatory knowledge

Auditing

Cross-functional collaboration

Educación

Bachelor's degree in relevant science

Descripción del empleo

CSL Behring Behring Kankakee site seeks a Quality Oversight lead to manage external supplier audits and ensure compliance with regulatory requirements across the M7/8 expansion project. You will direct audit programs, facilitate deviation investigations, and oversee supplier quality agreements.

The role requires a strong GxP background, extensive regulatory knowledge, and prior leadership experience in a global pharmaceutical environment.