QA Associate Director, Facility Operations 80-100%

Vor 3 Tagen
Visp, Valais, Schweiz Lonza Vollzeit
bOverview /b pIn this senior QA role at Lonza Visp, you will lead the integration of facility operation and pest control within the Contamination Prevention Control framework. You will oversee QA governance for site utilities, infrastructure interfaces, pest control, and GMP facility interfaces to ensure contamination prevention and inspection readiness. You will drive risk-based decisions, support audits, and guide cross-functional teams across operations, engineering, and regulatory functions. This position offers broad, impactful scope and a path to shape contamination control across a world-leading biologics site. /p bLeistungen / Benefits /bulliinclusive team /lilibroad high-impact scope /liliagile career culture /lililifestyle and family benefits /lilicompetitive compensation /lilitailored local benefits /li /ul bVerantwortungsbereiche /bulliProvide senior technical direction and risk-based quality guidance across the Visp site on facility operation and pest control topics. /liliMaintain QA oversight for site utility systems, facility interfaces, and GMP compliance with a focus on microbial and cross-contamination prevention. /liliOwn QA governance for deviations, change reviews, CAPA oversight, trend analysis, and quality risk assessments. /liliServe as QA SME during customer audits, regulatory inspections, internal audits, and project reviews. /liliOffer quality oversight for new projects, facility changes, utility standards, infrastructure readiness, and handover to routine operations. /liliCollaborate across QA Operations, QC, Hygiene, Engineering, Facilities, Utilities, Manufacturing, Regulatory, and Global Quality Engineering. /liliDrive continuous improvement of quality systems, inspection readiness, and GMP execution at the Visp site. /li /ul bZentrale Anforderungen /bulliAcademic degree in Life Sciences/ Engineering/ Pharmaceutical Sciences/ Biotechnology/ Quality or another relevant discipline /liliSignificant GMP-regulated pharmaceutical or biotech manufacturing experience with exposure to utilities, infrastructure, or site operations /liliStrong QA experience in leading complex topics and influencing cross-functional stakeholders without direct line management /liliSolid knowledge of GMP, deviations, CAPA, change controls, risk management, inspections, and audits /liliExperience with utilities, infrastructure, pest control, facility readiness, engineering interfaces, construction interfaces, or project handover (highly desired) /liliUnderstanding of contamination prevention, cleanroom operations, qualified utilities, and inspection readiness /liliAbility to translate complex topics into clear, risk-based decisions; English fluent; German advantageous /li /ulullicross-functional collaboration /liliinfluencing without direct authority /lilirisk-based decision making /liliGMP principles /liliDeviations and CAPA management /liliChange controls and risk management /li /ul

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