QA Sterility Assurance Manager

Lead the site's sterility assurance strategy, ensuring compliance with EU GMP Annex 1 and other global regulatory requirements while safeguarding product quality and patient safety. Drive and continuously enhance the Contamination Control Strategy (CCS) by providing expert oversight of contamination control, environmental monitoring, cleaning, disinfection, and aseptic manufacturing activities. Act as a trusted sterility assurance SME, supporting facility design, qualification, validation, technology transfers, new product introductions, and the implementation of innovative technologies. Champion a culture of quality and continuous improvement by leading risk assessments, trend analysis, training programs, and initiatives that strengthen sterility assurance performance across the site. Represent Quality Assurance during inspections, audits, and regulatory interactions, ensuring inspection readiness, fostering cross-functional collaboration, and shaping the future sterility assurance framework of a rapidly growing site.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Proven expertise in sterility assurance, with a deep understanding of EU GMP Annex 1 and hands-on experience implementing and maintaining Annex 1 requirements in a sterile manufacturing environment is a must.

• Strong knowledge of Contamination Control Strategy (CCS), including the ability to develop, challenge, and continuously improve contamination control programs that support product quality and patient safety.

• Extensive experience in aseptic processing, including media fills (APS), contamination risk management, and sterile manufacturing operations.

• Highly proactive and solution-oriented mindset, with a passion for identifying root causes, partnering closely with production teams, and implementing sustainable corrective actions to prevent recurrence.

• Excellent communication and influencing skills, with fluency in English and the confidence to represent the organization during audits and inspections; German language skills and audit experience are considered strong advantages.