Global Head of Sterility & Contamination Control

Lonza; Morristown (NJ); On-site; USD 190,000 - 250,000; Full time

Job summary

Lonza Group is seeking a Director, Sterility Assurance to provide global leadership for sterility assurance across its sterile manufacturing network. You will shape strategy, governance, and continuous improvement to ensure world-class contamination control and compliance.

You will lead risk assessments, CAPAs, and cross-site standardization, partnering with development, manufacturing, and regulatory teams to drive quality and operational excellence.

Qualifications

• Significant leadership experience in sterile GMP environments.
• Deep expertise in sterility assurance and microbiology.
• Experience supporting complex investigations and regulatory inspections.

Responsibilities

• Develop and drive global sterility assurance strategy across manufacturing sites.
• Lead risk assessments and CAPA implementation for contamination events.
• Harmonize sterility standards and environmental monitoring programs.
• Support product development, tech transfer, and new facility startups.
• Coach employees on biosafety and aseptic practices; regulatory readiness.

Skills

Leadership

Microbiology

Aseptic processing

Contamination control

Quality risk management

Communication

Stakeholder management

Global alignment

Education

Bachelor's degree in Microbiology or related

Master's degree or higher advantageous

Job description

Lonza Group is seeking a Director, Sterility Assurance to provide global leadership for sterility assurance across its sterile manufacturing network. You will shape strategy, governance, and continuous improvement to ensure world-class contamination control and compliance.

You will lead risk assessments, CAPAs, and cross-site standardization, partnering with development, manufacturing, and regulatory teams to drive quality and operational excellence.