QA Sterility Assurance Lead (SAL) – Drug Product

About the role

The Sterility Assurance Lead (SAL) will head the Sterility Assurance and Microbial Control Program for the Drug Product Module at Lonza’s Visp site. The role drives a strong sterility assurance culture, ensuring regulatory compliance and operational excellence across all contamination control and aseptic processing activities.

Key responsibilities

• Own and continuously improve the Contamination Control Strategy (CCS) in line with regulatory requirements, Lonza guidelines and industry best practices.
• Provide technical leadership for aseptic processing, aseptic process simulations (APS), sterilization, cleanroom management and contamination control programs.
• Act as the Sterility Assurance SME for facility design, technology transfers and contamination risk assessments.
• Lead investigations, corrective and preventive actions, and root‑cause analyses related to sterility assurance.
• Manage environmental monitoring strategies, performance metrics, trend analysis and continuous improvement initiatives.
• Represent Sterility Assurance during health authority inspections, customer audits and cross‑functional platforms.

Required profile

• Academic degree in a scientific discipline with extensive experience in microbial control and sterility assurance within the pharmaceutical industry.
• Strong hands‑on expertise in contamination control, aseptic processing, APS, environmental monitoring and complex microbiological investigations.
• Deep knowledge of cleanroom engineering, sterilization processes, microbiological testing methodologies and contamination risk management.
• Excellent communication, decision‑making and change‑management skills in complex operational environments.
• Comprehensive understanding of pharmaceutical regulations, GMP and USP/EP requirements.
• Business‑fluent English; German is an advantage.

Required skills

• Contamination control
• Aseptic processing
• Aseptic process simulations (APS)
• Sterilization techniques
• Cleanroom management
• Environmental monitoring
• Microbial control
• USP/EP compliance
• Bioburden and endotoxin testing
• Sterility testing

What we offer

• Agile career and dynamic working culture
• Inclusive and ethical workplace
• Compensation programs that recognize high performance
• Variety of benefits depending on role and location