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.
This role is primarily based on site in Stein, AG, Switzerland. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. Flexibility to work remotely for no more than 20% of your time is offered, with requests considered on a case‑by‑case basis in line with business needs. Relocation assistance is available for eligible candidates and their families, if needed.
Tasks
- 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.
Requirements
- 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.
Benefits
- 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.
Bist du Teil dieses Unternehmens?
Dieses Unternehmensprofil wurde automatisch erstellt. Wenn du für Lonza Group AG arbeitest, kannst du das Profil jetzt beanspruchen und verifizieren – kostenlos und in wenigen Minuten.