Senior QA Expert, Manufacturing 80-100%

Lonza is looking for a Senior QA Expert to join its manufacturing hub in Stein, AG, Switzerland. The position sits within a fast‑moving project team that prepares the site for full‑scale drug product production. The role is centred on guaranteeing quality compliance while the operation moves from start‑up to steady state, offering a unique chance to shape future manufacturing practices. On a daily basis the incumbent will supervise quality aspects of shop‑floor activities, confirming that all work follows GMP standards. Responsibilities include scrutinising and signing off standard operating procedures, work instructions and related documentation to enable a smooth launch and ongoing production. The expert will collaborate closely with manufacturing personnel to ready aseptic processes, provide training, and ensure that both automated filling lines and media‑fill exercises are set for execution. Managing quality incidents is also key: the role reviews deviations, drives corrective and preventive actions, and oversees investigations to secure timely resolutions. Additionally, the QA representative will voice quality considerations during project meetings, audits and inspections, helping the team stay inspection‑ready. The ideal candidate must have a solid background in the pharmaceutical sector, specifically within a GMP‑regulated environment and with hands‑on experience in sterile or drug‑product manufacturing. Proven capability in overseeing deviations, CAPAs and investigations is essential, as is fluency in both German and English to interact effectively with operators, cross‑functional groups, customers and regulators. The position demands a willingness to spend considerable time on the production floor, including full aseptic gowning, and a pragmatic, solution‑focused attitude. Academic credentials should comprise at least a bachelor’s degree, with a master’s or PhD in life sciences, pharmacy, chemistry, biology, biotechnology or a closely related discipline. Lonza supports relocation for qualified candidates and their families, and allows up to 20 % of work time to be performed remotely when business needs permit. The company promotes an agile career path, a collaborative and ethical workplace, and a broad portfolio of lifestyle, family and leisure benefits. Employees join a global network of more than thirty sites across five continents, contributing to the creation of medicines that improve millions of lives while working in an inclusive environment that values diverse perspectives. What the role asks for: - Proven GMP‑regulated pharma experience with sterile manufacturing - Experience overseeing deviations, CAPAs, investigations - Fluent German communication - Fluent English communication - Willingness to work extensively on shopfloor in aseptic gowning - Bachelor’s, Master’s or PhD in Life Sciences or related field - Nice‑to‑have: audit and inspection support experience