Global Director, Sterility Assurance & Contamination Control

Lonza; United States; Remote; Confidential; Full time

Job summary

Lonza is seeking an experienced Director, Sterility Assurance to provide global leadership for sterility assurance and contamination control across Lonza’s sterile manufacturing network. This highly visible role will shape enterprise-wide strategy, governance, and continuous improvement to ensure world-class contamination control and compliance across drug substance and drug product operations.

The role emphasizes risk management, cross-site collaboration, and regulatory readiness, plus coaching

Qualifications

• Significant leadership experience within sterile GMP-regulated environments.
• Deep expertise in sterility assurance, contamination control, and microbiology.
• Demonstrated experience supporting investigations, contamination events, and regulatory inspections.
• Proven success leading within global, matrixed organizations.

Responsibilities

• Develop and implement sterility strategies addressing adventitious agent risks.
• Lead global sterility assurance strategy, risk assessments, CAPAs and gap closure.
• Harmonize sterility standards and contamination control programs across sites.
• Act as global SME for product development, tech transfer, and new products.
• Coach staff and support regulatory inspections and audits.

Skills

Expert knowledge of sterile GMP

Contamination control

Communication & coaching

Global alignment

Continuous improvement

Education

Bachelor’s/Master’s or higher in Microbiology or Life Sciences

Advanced scientific qualifications or certifications

Job description

Lonza is seeking an experienced Director, Sterility Assurance to provide global leadership for sterility assurance and contamination control across Lonza’s sterile manufacturing network. This highly visible role will shape enterprise-wide strategy, governance, and continuous improvement to ensure world-class contamination control and compliance across drug substance and drug product operations.

The role emphasizes risk management, cross-site collaboration, and regulatory readiness, plus coaching