QA Sterility Assurance Manager

About the role

Lead the sterility assurance strategy at Lonza's site in Stein, ensuring compliance with EU GMP Annex 1 and safeguarding product quality and patient safety. The role combines on‑site collaboration with up to 20% remote work, supporting cross‑functional teams and regulatory interactions.

Key responsibilities

• Develop and maintain the Contamination Control Strategy, overseeing environmental monitoring, cleaning, disinfection and aseptic manufacturing.
• Act as the sterility assurance subject‑matter expert for facility design, qualification, validation, technology transfers and new product introductions.
• Lead risk assessments, trend analysis, training programs and continuous‑improvement initiatives to enhance sterility performance.
• Represent Quality Assurance during inspections, audits and regulatory engagements, ensuring inspection readiness.

Required profile

• Proven expertise in sterility assurance with hands‑on implementation of EU GMP Annex 1 in a sterile manufacturing environment.
• Extensive experience in aseptic processing, media fills and contamination risk management.
• Highly proactive, solution‑oriented mindset with strong root‑cause analysis skills.
• Excellent communication and influencing abilities; fluency in English required, German and audit experience are strong advantages.

Required skills

• EU GMP Annex 1 compliance
• Contamination Control Strategy development
• Aseptic processing and media fills
• Risk assessment and trend analysis

What we offer

• Agile career with a dynamic work culture
• Inclusive and ethical workplace
• Competitive salary and comprehensive lifestyle, family and leisure benefits