Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.We are looking for a Senior QA Specialist/QA Project Manager (f/m/d) for our BioAtrium organization. The QA Specialist, Project Manager specifies quality requirements for manufacturing processes and ensures that manufactured products comply with national and international requirements and cGMP standards over their entire life cycle. As a Quality and Compliance representative you will be a key member in cross-functional project teams ensuring measures for product safety, product quality & cGMP compliance are implemented. You will have full QA oversight of a product and manage the project from Quality perspective.What you will get:An agile career and dynamic working cultureAn inclusive and ethical workplaceCompensation programs that recognize high performanceA variety of benefits dependant on role and locationThe full list of our global benefits can be also found on .What you will do:Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for commercial supply. This includes oversight of QC / logistic / supply chain / manufacturing related activitiesRepresent QA in project / tech transfer organizations for new biotech manufacturing processesCoordinate QA interests during the different project phasesMake quality decisions for the respective projects in internal and external meetingsResponsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.Perform assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where requiredSupport the investigations of customer product complaints and assure the completion of the appropriate documentationIdentify emerging QA relevant topics, communicate to the IBEX QA organization and work actively on their development into new or already established Quality and Compliance strategies and/or standardsInvolvement in generation of Annual Product Quality ReviewsParticipate and support regulatory inspections and customer auditsWhat we are looking for:Academic degree in Biotechnology/ Biology/ Chemistry or related fieldSignificant experience in the area of biopharmaceutical manufacturing, preferably in a QA functionStrong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches and risk managementSound experience in representing Quality and Compliance in projectsGood communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS and SAPExcellent written and spoken English is required; knowledge of German (written and spoken) is an advantageAbout LonzaAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.Ready to shape the future of life sciences? Apply now.
