Global Sterility Assurance Leader: Standards & Compliance

BioSpace; Kankakee (IL); On-site; USD 120,000 - 210,000; Full time

Job summary

CSL Behring is seeking a senior leader in Sterility Assurance within Global Quality Operations to oversee sterility programs across CSL sites and CMOs, ensuring compliance with the highest regulatory standards.

The role drives proactive risk management, inspection readiness, and strategic initiatives for sterile filling, filtration, lyophilization, and bioburden control. Strong collaboration with global functions is essential.

Qualifications

• Bachelor’s degree in microbiology, biology or life sciences.
• 8–10 years in pharmaceutical manufacturing with QA/sterility experience.
• Experience with GxP, FDA/EU regulatory guidelines.

Responsibilities

• Provide strategic leadership on sterility assurance standards, culture and continuous improvement.
• Provide regulatory and business intelligence on sterile manufacturing and Sterility Assurance.
• Collaborate with global teams to develop holistic microbial contamination control strategies at sites.

Skills

Sterility Assurance

Quality leadership

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in microbiology or biology

Job description

CSL Behring is seeking a senior leader in Sterility Assurance within Global Quality Operations to oversee sterility programs across CSL sites and CMOs, ensuring compliance with the highest regulatory standards.

The role drives proactive risk management, inspection readiness, and strategic initiatives for sterile filling, filtration, lyophilization, and bioburden control. Strong collaboration with global functions is essential.