QA Manager - Contamination Control Strategy

QA Manager - Contamination Control Strategy

Lonza

Visp, Switzerland

You will own defined parts of the site Contamination Control Strategy at one of the largest biologics manufacturing sites in the world, where your decisions shape how a sustained microbial state of control is held shift after shift, batch after batch. You will work alongside colleagues from across the globe, in a site set in the Swiss Alps of the Valais.

What you will do:

• Own defined areas within the site Contamination Control Strategy and hold a sustained microbial state of control across facilities, equipment, processes, and supporting systems.
• Act as the technical lead for contamination control, hygiene, and microbiological QC topics in deviations, change controls, root cause investigations, impact assessments, and CAPAs, including their definition and follow-up.
• Ensure equipment, facility, and process hygienic integrity across the full lifecycle, from design and qualification through start-up, routine use, cleaning and sanitization, maintenance, and bioburden remediation.
• Provide visible shopfloor presence, hands-on technical support, day-to-day guidance, and leadership on contamination control, hygiene, and microbiological QC topics, including GEMBAs, oversight of microbiological methods and testing, and alignment of data trending practices with site contamination control requirements.
• Develop and improve hygiene concepts, gowning expectations, aseptic behavior, microbial hold times, bioburden and endotoxin control strategies, and the associated risk assessments.
• Represent CCS and microbiological quality topics in projects, audits, regulatory inspections, and cross-functional governance forums spanning QA, QC, MSAT, Engineering, Validations, and Operations.
• Drive continuous improvement, KPI delivery, training, and technical guidance commensurate with the risk profile of the site, and stay current with evolving regulatory expectations and industry best practice.

What we are looking for:

• Academic degree in Microbiology/Biotechnology/Pharmaceutical Sciences or another relevant scientific discipline.
• Significant experience in GMP-regulated pharmaceutical or biotech manufacturing, with strong exposure to contamination control, microbiological quality, or sterility assurance-related topics.
• Hands-on experience in contamination control strategy, microbial risk management, and contamination prevention in manufacturing environments is highly desired.
• A Quality Assurance background is preferred, particularly in roles involving contamination control, deviations, change controls, investigations, CAPAs, and inspection readiness.
• Good knowledge of GMP requirements and relevant regulatory expectations, including EU GMP Annex 1, EudraLex Volume 4, and applicable pharmacopoeial requirements and microbiological compendia.
• Understanding of key contamination control elements such as environmental and utilities monitoring, hygiene, gowning, aseptic practices, microbial control strategies, cleanroom behaviors, and qualified state maintenance.
• Strong communication and stakeholder-management skills, with the ability to collaborate effectively across QA, QC, Engineering, Operations, and Microbiology.
• Fluency in English (written and spoken), German is an advantage.