QA Sterility Assurance Manager 80-100%

Lonza; Stein (AR); Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Stein, Switzerland, is seeking a Sterility Assurance lead to drive compliance with EU GMP Annex 1 and strengthen contamination control across a growing site.

You will champion aseptic manufacturing excellence, support product introductions, and collaborate with global teams to safeguard patient safety and product quality. On-site role with up to 20% remote work, fostering real-time collaboration and technical precision.

Qualifikationen

• Proven expertise in sterility assurance and compliance with EU GMP Annex 1 requirements.
• Experience implementing and maintaining Annex 1 in sterile manufacturing environments.
• Strong knowledge of CCS and contamination control programs.
• Hands-on experience with aseptic processing and media fills is preferred.
• Excellent communication and ability to influence at audits and inspections.

Aufgaben

• Lead the site's sterility assurance strategy with regulatory compliance focus.
• Oversee Contamination Control Strategy, including environmental monitoring and cleaning.
• Support facility design, qualification, validation, tech transfers, and new product introductions.
• Drive risk assessments, trend analyses, and training to elevate sterility performance.
• Represent QA during inspections and regulatory interactions; ensure readiness.

Kenntnisse

Sterility assurance

EU GMP Annex 1

Contamination control

Aseptic processing

Root-cause analysis

Cross-functional collaboration

English proficiency

German language

Jobbeschreibung

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Play a pivotal role in safeguarding products for patients by driving sterility assurance, contamination control, and quality excellence across a rapidly expanding site. Working closely with global networks and cross-functional teams, you will influence strategic decisions, strengthen compliance with evolving regulations, and help build the future of sterile manufacturing. Check out Your Career in Drug Product Services at Lonza!

This role is primarily based on site. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case-by-case basis, in line with business needs.

What you will get:

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

Our local benefits: 3cf206339e0e4e41a77e8c806138c2b5

What you will do:

• 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.

What we are looking for:

• 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.

About Lonza

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.