Quality lead

About SerovaSerova builds personalized cancer vaccines. Each vaccine is made for the individual patient from their own samples and given in partnership with their treating physician. We're building a lab, a manufacturing facility and a clinic at the same time, and every batch we make is for a single patient.The roleWe're building a lab, a manufacturing facility and a clinic, and all of them need a quality system. You'll build a fit-for-stage GxP quality management system across them and keep it working as we grow.What you'll doBuild and mature our GxP quality management system: SOPs, document control and training recordsRun deviations, CAPAs and change controlQualify vendors and CDMOs and put quality agreements in place, including with our manufacturing partnersSet up the batch release process for patient-specific productProvide quality oversight across product development, manufacturing, expanded access and clinical workPlan audits of sites and vendors, and get us inspection-ready, including our Bozeman clinicSet quality rules for our digital systems, automation, data integrity and AI-enabled workflows, built so they don't slow us downOwn change control for our in-house software and analysis pipeline, which updates oftenWho you areA hands-on quality lead who builds proportionate, risk-based systems from the ground upYou would never import a big-pharma QMS wholesaleComfortable with both the framework and the detailHigh agency, friendly and low egoRequirementsHands-on clinical quality (GCP) experience, not only GMP, plus a working knowledge of GMPYou've run audits, investigations, CAPAs and change controlBased in the San Francisco Bay Area or London, or remote with regular site visitsAuthorized to work in the US or UK, or a realistic path to get thereWhat will make you stand outYou've built a QMS at an early-stage biotechnology companyQuality for digital and automated systems: data integrity, computerized systems, AI-enabled workflowsBiologics, advanced therapies or oncologyVendor and CDMO qualification, quality agreements, batch releaseMulti-site clinical quality, including site readiness and inspectionsDetailsLocation: San Francisco or London, or remote with site visitsType: Full-timeJ-18808-Ljbffr