QA Manager

Responsible for Equipment, QC, Computerized System Validation (CSV) and Automation deliverables for new aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products. Representing Quality in the CAPEX project organization in regards to Equipment, QC, Computerized System Validation (CSV) and Automation. Reviewing and releasing quality related to Equipment, QC, Computerized System Validation (CSV) and Automation project deliverables. Ensuring Equipment, QC, Computerized System Validation (CSV) and Automation deliverables meet Global procedures, regulatory requirements and policies. Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal and external project stakeholders.

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.

• Bachelor or Master degree in computer science, engineering, life science or related field

• Significant experience in the GMP regulated pharmaceutical industry project; preferable in a role within a Quality Unit

• Knowledgeable in commissioning and qualification of aseptic manufacturing systems and QC analytical systems, Annex 1 requirements

• Knowledgeable in CSV, Data Integrity, Automation systems and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)

• Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)

• Sound knowledge of MES and DCS is required

• Fluency in English, German would be an advantage