ppToday, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. /ppWe are looking for a Head of Quality for BioAtrium, based in Visp, Switzerland. /ppBioAtrium’s Head of Quality is responsible for all quality-related aspects of the activities undertaken at the site, in accordance with all applicable laws and regulations including quality agreements entered into with Sanofi and Lonza. /ph3Key Responsibilities /h3ulliQuality strategy and Leadership at BioAtrium AG: The Head of Quality defines quality vision and quality strategy. The quality vision and quality strategy will be based on the overall vison and strategy of BioAtrium. The quality vision will foster compliance, risk and science thinking to direct the quality organization towards a modern organization having eventually the patient’s wellbeing in top of their mind. On periodic basis, milestone plans with defined quality initiatives to ensure to follow the quality strategy will be defined and subsequently executed. Acts as a change agent, driving high Quality Standards and a culture of continuous improvement. Develops talents through coaching and fostering continuous learning. /liliQuality Management System of BioAtrium: Head of Quality maintains a compliant quality management system at BioAtrium: Monitoring of key performance indicators to assess the efficiency of the quality system, of the quality culture, and of appropriate staffing. Assures qualified status of facility, equipment, processes and cleaning, test methods, IT infrastructure and application during the lifecycle of products, of related systems and of the facility. Follows up on current GMP trends and ensures that plans are in place to maintain BioAtrium in a state of compliance. /liliOversight of all outsourced services as well as management of any incoming complaints. /liliInspection and regulatory agencies: The Head of Quality maintains an active and successful collaboration with Swissmedic to ensure the Manufacturing License for BioAtrium according to the Medicinal Products Licensing Ordinance (SR 812.212.1) including successful inspections of the BioAtrium facility. This includes also the collaboration with all foreign health authorities as well as any customer inspections to ensure the site is inspection-ready at any time. Ensure a smooth inspection organization including the set-up of back and front office, timely and adequate response to inspection observations and focused follow-up on all CAPA plans. /li /ulh3Key Requirements, Qualifications, Skills Behavior /h3ulliMaster Degree in Life Sciences or related education. /liliSeveral years’ of experience in leading GMP biopharmaceutical quality operations. /liliMany years’ of experience leading multi-disciplinary teams in pharma, vaccines or biopharmaceuticals. /liliDemonstrated leadership of site management teams. /liliStart-up experience of manufacturing facilities or businesses. /liliExpert in Quality understanding of Drug Substance (ICH Q7) and understanding current trends. /liliExpert in GMP manufacturing of biopharmaceutical Drug Substances. /liliKnowledge of development and technology transfer of therapeutic protein processes. /liliTrained in Operational Excellence in a GMP environment. /liliQuality and GMP compliance mindset. /liliCustomer facing skills. /liliRepresenting the Joint venture to customers, regulatory inspectors and stakeholders. /liliEnglish and German language is essential. /liliFrench language is an advantage. /li /ul /p #J-18808-Ljbffr
