We are 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 drive enterprise-wide strategy, governance, and continuous improvement initiatives to ensure world-class biological contamination control and compliance across sterile drug substance and drug product operations.
Key ResponsibilitiesGlobal Sterility Assurance Leadership- Develop, implement, and continuously improve biological contamination control strategies addressing viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious agent risks.
- Drive and oversee the global sterility assurance strategy, including risk assessment, mitigation planning, gap closure, and sustainable implementation across manufacturing sites.
- Serve as a global subject matter expert and strategic leader for contamination control and aseptic manufacturing practices.
Risk Management and Site Support- Lead global sterility assurance risk assessments and support sites in responding to contamination events, sterility failures, microbiological excursions, and adverse trends.
- Facilitate root cause investigations and implement effective corrective and preventive actions (CAPAs) across the network.
- Promote cross-site collaboration, knowledge sharing, and implementation of best practices.
Network Standardization and Continuous Improvement- Drive harmonization of sterility assurance standards and contamination control programs across global sites.
- Establish and improve procedures governing facility and equipment design, process design, material transfer, environmental monitoring, microbiological testing, maintenance, cleaning, disinfection, and segregation controls.
- Champion continuous improvement initiatives that strengthen contamination control, consistency, and inspection readiness.
New Product Introduction and Technical Expertise- Act as the global sterility assurance expert for product development, technology transfer, and new product introductions.
- Ensure phase-appropriate sterility assurance practices are embedded throughout development and commercial manufacturing programs.
- Support network expansion projects and new facility start-ups as required.
Capability Building and Regulatory Support- Coach and train employees to strengthen understanding of biological risks, contamination control, and aseptic behaviors.
- Support regulatory inspections, customer audits, GQC audits, mock pre-approval inspections, due diligence activities, and other compliance initiatives as a sterility assurance SME.
- Monitor evolving industry and regulatory expectations and ensure timely implementation across the network.
What You'll BringEducation- Bachelor's, Master's, or higher degree in Microbiology, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, or a related scientific discipline.
- Advanced scientific qualifications or certifications are advantageous.
Experience- Significant leadership experience within sterile pharmaceutical, biotechnology, biologics, cell and gene therapy, or related GMP-regulated environments.
- Deep expertise in sterility assurance, contamination control, microbiology, aseptic processing, and quality risk management.
- Demonstrated experience supporting complex investigations, contamination events, and regulatory inspections.
- Proven success influencing and leading within global, matrixed organizations.
Skills- Expert knowledge of sterile manufacturing regulations and industry standards.
- Strong understanding of contamination control strategies and microbiological risk assessment.
- Excellent communication, coaching, and stakeholder management skills.
- Ability to drive global alignment while balancing site-specific operational needs.
- Continuous improvement mindset with a passion for scientific excellence and operational effectiveness.
Apply today and help shape the future of sterility assurance across Lonza's global manufacturing network.
