• Oversee Quality Assurance (QA) and Quality Control (QC) functions across all GXP areas,including GMP, GCP and GLP.• Responsible for ensuring quality and compliance of all GXP related activities supportingmanufacturing, testing and clinical investigation of cell therapy products.• Lead the design, implementation and maintenance of phase-appropriate quality systems andprocesses to support clinical development of cell therapy products.• Led the qualification and launch of new ISO7 cleanroom facilities for aseptic manufacturingof cellular products in compliance with cGMP requirements.• Provide quality oversight on contract development and manufacturing organizations(CDMOs) and other key suppliers to ensure consistent quality and compliance.• Maintain an effective supplier management program, including supplier qualification/audit,developing Quality Agreements, and monitoring of key performance indicators.• Drive and cultivate a culture of quality, proactive compliance and continuous improvement.

• Led a high-performing QA Operations team to support R&D, ProcessDevelopment, Assay Development, MSAT, Material Management, Facilities, QC andClinical Manufacturing.• Led quality support and oversight for internal manufacturing, testing and release of multipleiPSC-derived cell therapy products for clinical development.• Collaborated with CDMOs to ensure timely supply and release of materials and clinicalproducts complying with appropriate cGMP requirements and internal standards.• Managed external inspections by strategic partners and GXP auditors.• Led quality support and oversight for the qualification of a new cGMP facility for clinicalmanufacturing.• Provided oversight and guidance for all quality and compliance topics/issues related to CMCactivities, manufacturing operations, QC testing and product supply.• Ensure thorough and complete investigation of deviations and Out-of-Specification (OOS)results with development of appropriate corrective and preventive actions (CAPA).• Continuously evaluated quality and compliance gaps and collaborated with relevant functionsto develop and implement improvement actions.

• Built and led the Early Development QA team to provide quality support and oversight toadvance multiple AAV-based gene therapy programs towards IND.• Led QA oversight on CMC and GMP QC testing for preclinical and clinical batches acrossmultiple sites.• Developed and implemented quality systems to provide appropriate quality framework foractivities supporting gene therapy development.• Collaborated with Commercial Quality to ensure site inspection readiness, supported FDAinspection and follow up responses.• Collaborated cross-functionally to identify quality/compliance gaps and driveimplementation of new standards and procedures.

• Provided Quality oversight and support for advanced therapy projects (e.g. cell & genetherapy), including quality oversight/audit for key studies, review of study reports and INDsubmissions.• Conducted quality audits of external service providers and contract testing labs.• Led internal audit and risk assessment to support remediation activities following FDAinspections.• Led NIBR Data Integrity (DI) Program, in collaboration with Novartis TechOps and ClinicalQuality DI teams to develop and implement DI strategies for Novartis.• Supported quality evaluation of merger & acquisition projects as a member of the NovartisDue Diligence team.

• Designed and implemented a data quality monitoring program across NIBR to ensure dataintegrity and regulatory compliance.• Provided quality support and oversight for all NIBR functional groups.• Collaborated with IT, Operations, Communication and Legal to develop and implement newprocesses and guidance documents to improve and promote Data Quality and Data Integrity.

• Project Team Leader (PTL) on multiple pipeline programs.• Developed project strategies and drove critical activities to identify and advance leadmolecules for heart failure and obesity.• Led multidisciplinary and cross-functional project teams to advance projects.• Evaluated new technologies and managed external research collaborations.

• Validated novel targets that resulted in the approval of two new pipeline projects.• Led discovery programs to identify and validate novel targets for cardiovascular andmetabolic diseases.• Developed and optimized key cell-based assays to characterize lead compounds.• Completed medium-throughput screens of peptide and compound libraries for targetidentification.