QA Manager

Lonza seeks a QA Manager in Stein, Switzerland, to lead quality assurance for a major aseptic fill-finish facility project, ensuring compliance with GMP and regulatory standards.

This position plays a key role in supporting business expansion at the Stein site by integrating into an international, cross-functional team. The manager will oversee quality assurance activities for a large-scale aseptic fill-finish facility project, ensuring all deliverables align with global standards and regulatory expectations.

Responsibilities

• Oversee validation and automation deliverables for equipment, QC systems, and computerized systems within new aseptic manufacturing facilities.
• Act as the primary Quality representative within the CAPEX project structure, focusing on equipment, QC, CSV, and automation aspects.
• Evaluate and approve quality documentation associated with project deliverables for equipment, QC, CSV, and automation.
• Verify that all project outputs comply with global procedures, internal policies, and applicable regulatory requirements.
• Serve as a subject matter expert, offering strategic guidance and recommendations to both internal teams and external stakeholders.

Requirements

• Bachelor’s or Master’s degree in computer science, engineering, life sciences, or a related discipline.
• Extensive background in GMP-regulated pharmaceutical projects, ideally within a Quality Unit role.
• Strong understanding of commissioning and qualification for aseptic manufacturing and QC analytical systems, including Annex 1 requirements.
• Proficiency in CSV, data integrity, and automation systems, with knowledge of 21 CFR Part 11, EU GMP Annex 11, and GAMP5.
• Proven ability to interact with diverse organizational interfaces and regulatory bodies such as Swissmedic and the FDA.
• Solid expertise in Manufacturing Execution Systems (MES) and Distributed Control Systems (DCS).

Nice to have

• Fluency in German.

What the company offers

• Relocation support for eligible candidates and their families.
• Opportunities for agile career development within a dynamic work environment.
• An inclusive and ethical workplace culture.
• Compensation structures that reward high performance.

About the company

Lonza fosters a work environment grounded in collaboration, accountability, excellence, passion, and integrity. The company is dedicated to maintaining diversity and ensuring an inclusive atmosphere for all employees.

• Core values include collaboration, accountability, excellence, passion, and integrity.
• Commitment to diversity and an inclusive environment for all staff.