Descripción de la oferta
Experteer Overview Compruebe que cumple con los requisitos de habilidades para este puesto, así como con la experiencia asociada, y luego envíe su CV a continuación. As Product Quality Lead, you guide end-to-end quality stewardship for Novartis biologics from late development through discontinuation. You partner with QC, AS&T, MS&T and ESO QA to ensure global quality standards across the product lifecycle. You lead quality strategy, investigations, and regulatory readiness, driving improvements and harmonization across the network. This role offers meaningful impact by shaping product quality as a competitive advantage within a cross-functional, global setting.Compensaciones / Beneficios• Oversee end-to-end quality stewardship (DS and DP) for assigned biologics globally• Define and drive end-to-end product quality strategy across the lifecycle• Provide expert quality guidance and leadership for quality guidelines, regulations, and processes• Maintain global quality oversight and support regulatory filings and variation management• Act as global quality lead for escalations, recalls, and BPDR handling• Lead and support major investigations, site-wide deviations, and multi-site task forces• Support site readiness for pre-approval inspections across BT&A platform/network• Facilitate cross-functional collaboration to execute the Product related Quality Program• Drive platform-wide Q strategy harmonization and quality-driven competitive advantageResponsabilidades• 5+ years of experience in an operational GxP area in Manufacturing/Development or Quality• Solid knowledge in biology/chemistry, xcskxlj pharmacy and biotechnology, medical devices/combination products• Thorough knowledge of cGMP and applicable guidelines• Sound scientific, technical and regulatory knowledge; biotech experience preferred; validation expertise a plus• Proven ability to analyse and evaluate cGMP compliance• Proven ability to influence people and communicate in a process-oriented organization• Fluent English, written and spoken; additional languages a plusRequisitos principales•
