Senior QA Expert, Manufacturing (80-100%)

About the role

Lonza is hiring a Senior QA Expert for a manufacturing project in Stein, Switzerland, where the role is primarily based on site. The position drives operational readiness from a quality perspective, covering robust documentation, SOP compliance, aseptic process preparedness and oversight of deviations and CAPAs. It suits professionals moving from production into Quality Assurance, with relocation assistance available for eligible candidates and their families.

Key responsibilities

• Provide QA oversight of shopfloor manufacturing activities in a growth project, ensuring GMP compliance and operational readiness.
• Review and approve SOPs, work instructions and other GMP documentation to support start-up and sustainable manufacturing.
• Partner with Manufacturing teams on aseptic process readiness, including preparation, training support and execution readiness for APS and future media fill activities.
• Lead and coordinate quality events by reviewing and approving deviations, CAPAs, investigations and related quality records.
• Act as the Quality representative during project discussions, audits and inspections, communicating the quality oversight strategy and supporting inspection readiness.

Required profile

• Proven experience in the pharmaceutical industry in a GMP-regulated environment; expertise in sterile and/or drug product manufacturing is a must.
• Experience in quality oversight, managing deviations, CAPAs and investigations.
• Fluent German and fluent English.
• Willingness to spend significant time on the shopfloor, including full aseptic gowning.
• Bachelor's, Master's or PhD in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology or a related field.
• Advantage: experience supporting regulatory and customer audits and inspections.

What we offer

• A competitive salary plus lifestyle, family and leisure benefits.
• An agile career, dynamic work culture and an inclusive, ethical workplace.
• Compensation programs that recognise high performance.
• Flexibility to work remotely for no more than 20% of the time, assessed case by case.