ProductQualityLead

**Job Description Summary** The Product Quality Lead plays a crucial role in ensuring the quality and consistency of our products throughout their lifecycle. This role encompasses a wide range of responsibilities that bridges clinical, development, and technical operations, providing expert guidance and leadership to ensure the highest quality standards for our products. The PQL collaborates with various teams during different phases of product development, from preclinical to postapproval changes. The PQL works closely with Quality Control (QC), Analytical Science & Technology (AS&T), Manufacturing Science & Technology (MS&T) and ESO QA teams to ensure product quality. **Job Description** **Major accountabilities:** * Accountable for end-to-end quality stewardship (DS and DP) of assigned Novartis biologics product(s) (NBE’s and biosimilars) from late phase development to discontinuation. * Accountable for the end-to-end product quality strategy (DS and DP) across the global network and drive continual improvement through product and process lifecycle management, represent QBT&A in cross-functional project life cycle team. * Provide expert quality guidance, technical support and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle. * Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned Novartis biologics product(s) (NBE’s and biosimilars) * Act as global quality lead in product related Q escalations, recalls and BPDR handling for product specific quality and compliance challenges. Provide clear direction and drive efficient decision making for global Quality issues related to assigned products. * Involved in major product relevant investigations, in particular multi-sites deviations and recurring devia-tions, by leading / supporting global investigat