Senior QA Expert Manufacturing Oversight - foster QA

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 key role in keeping sterile manufacturing running safely and smoothly, working closely with production teams to spot issues early and turn them into improvements. This is a hands‑on role with real impact, offering visibility on the shop floor, strong collaboration across teams, and the chance to shape a positive, proactive quality culture. In order to be close to the process you will be working in a cleanroom environment several times a week (preferably daily.

Check out Your Career in Drug Product Services at Lonza!

• 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. Our full list of tailored local benefits can be found below.

• Benefits in Stein: (Use the "Apply for this Job" box below)./42
  
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• Establish and maintain Quality Oversight for DPS Manufacturing, with a strong focus on aseptic/sterile manufacturing, environmental monitoring, process simulations (APS), visual inspection and personnel qualification. Act as a quality advisor and business partner to manufacturing and internal stakeholders on GMP and compliance topics.
• Ensure effective implementation and ownership of the GMP Quality System in Sterile Production Stein, including SOP ownership and quality oversight activities.
• Review and approve quality protocols, reports, and EM trending, including APS, cleaning and holding time studies, and equipment/room qualifications.
• Oversee GMP‑compliant material and personnel flows within sterile manufacturing operations.
• Lead and execute GMP compliance activities, including change control, deviations, document management, among others. Support and lead quality-related projects, continuous improvement initiatives and development of QA tools and processes.
• Represent QA during inspections, audits, and self‑inspections, as well as in local and global quality initiatives.
• Serve as the primary QA contact for sterile manufacturing compliance issues

• Solid experience in the GMP controlled environment in Quality Assurance or Aseptic manufacturing
• You have a sound experience in deviation handling, ideally certified for deviation handling
• Experience in QA manufacturing oversight is preferred
• Fluency in German & fluency in English is a must
• Willing to work in shifts
• Willing to be present in the manufacturing area in the cleanroom (full gowning is necessary) preferably daily