Sterility Assurance Manager - EU GMP Expert & CCS Leader

Lonza Group Ltd.; Stein; Hybrid; Confidential; Full time

Benefits offered by this job

Remote work up to 20%

Job summary

Lonza Group Ltd. in Stein, Switzerland is seeking an experienced senior professional to lead the site's sterility assurance strategy and ensure compliance with EU GMP Annex 1 and global requirements.

You will drive the Contamination Control Strategy, oversee environmental monitoring, cleaning, disinfection, and aseptic manufacturing, and partner with cross-functional teams to strengthen quality and patient safety while supporting inspections and regulatory interactions.

Qualifications

• Proven expertise in sterility assurance with EU GMP Annex 1 experience.
• Strong Contamination Control Strategy knowledge and implementation experience.
• Experience in aseptic processing and media fills.
• Excellent communication; English fluency; German language skills considered advantageous.

Responsibilities

• Lead site's sterility assurance strategy ensuring EU GMP Annex 1 compliance.
• Drive and improve CCS with oversight of contamination control and environmental monitoring.
• Support facility design, validation, tech transfers, and new product introductions.
• Lead risk assessments, trend analysis, training, and continuous improvement.
• Represent QA during inspections and regulatory interactions.

Skills

Sterility assurance

EU GMP Annex 1

Contamination Control Strategy

Aseptic processing

Media fills

Regulatory audits

English fluency

German advantageous

Job description

Lonza Group Ltd. in Stein, Switzerland is seeking an experienced senior professional to lead the site's sterility assurance strategy and ensure compliance with EU GMP Annex 1 and global requirements.

You will drive the Contamination Control Strategy, oversee environmental monitoring, cleaning, disinfection, and aseptic manufacturing, and partner with cross-functional teams to strengthen quality and patient safety while supporting inspections and regulatory interactions.