Claudia M. Lombardo

Dynamic quality leader with extensive experience in transforming quality systems in highly regulated environments. Proven track record of implementing effective quality strategies and governance frameworks that have consistently improved compliance metrics and operational excellence. Adept at fostering cross-functional collaboration to drive continuous improvement and risk mitigation.

• University of California, Berkeley, Graduated with “Distinction”
• Miramonte Ecole, Montreux, Switzerland, Graduated with “Tres Honorable”

• Quality Management Systems (Veeva, TrackWise, Agile, Qualio)
• Quality Management Systems implementation and improvements (Veeva, TrackWise, Agile, Qualio)
• GxP Audits/Vendor Management
• Performing Audits
• Quality Assurance Operations
• Risk Management and mitigation strategies
• Deviation/CAPA/Change Control
• Operational Excellence
• Gap Analysis
• Due Diligence
• Inspection Readiness
• Lean Practices
• Strategic Planning

• English
• French
• Spanish
• English
• French

• Bayer, Premier Circle 2009
• Bayer, Premier Circle 2011
• Genentech, Enemy of Chaos 2014

• Head of Quality (Document Control, QMS, Audit Management, Operations, Training), Alector Therapeutics, 05/01/25, 05/01/26, Oversee Document Control activities in Veeva (EDMS), Establish and maintain global document control standards, policies, and governance aligned with regulatory and quality requirements., Ensure consistent execution of document lifecycle management, including creation, review, approval, archival of documentation and periodic reviews of SOPs., Established and lead SOP Governance Board bringing cross functional teams together for discussing and aligning on new SOPs and updates to SOPs., Drive harmonization and standardization of document control practices across regions and functions., Oversee the management and ongoing enhancement of the Quality Management System (QMS), ensuring its effectiveness and compliance across GxP areas., Continue to build and expand Alector’s Quality System to ensure that it is optimally designed and implemented., Conduct ongoing analysis of Alector Policies and SOPs and lead the implementation of strategic initiatives to create, modify, or obsolete processes as needed., Collaborate with Functional Area stakeholders to develop and execute on risk-based annual Audit plans, including oversight of auditor assignments, audit tracking and timeline completion and filing of all audit documentation., Provide direction to staff supporting management of deviations, CAPAs, change control processes, training, document management, and Audit program management., Lead the development of Quality System metrics, provide analysis related to Functional Area performance and compliance, and collaborate with Functional Area leadership to assess trends and initiate continuous improvement programs., Oversee cGMP Quality team activities to ensure that functional areas within Alector as well as CMO/CDMO are operating in compliance with Alector’s Quality Management System (QMS) and applicable global regulations and guidelines., Ensure review and approval of product-related documentation (batch records, product disposition, labels) is conducted in a compliant and timely manner according to relevant Alector SOPs., Oversee the remediation of GMP audit findings, including review and approval of Vendor CAPAs., Assist with establishing metrics and reporting the state of GMP Quality and compliance of ongoing programs to senior management., Oversee Quality Control activities at Contract test lab., Oversee cross-functional collaborations to ensure Alector’s GxP validated systems align with the evolving needs of the organization and regulatory requirements, including system implementation, validation, and lifecycle maintenance., Facilitate training and knowledge-sharing sessions to enhance user understanding and engagement with GxP Systems and QMS processes., Lead proactive user communication and change management approaches supporting the implementation of system changes and deployment., Serve as a liaison with commercial partners to fulfill requests for documentation., Foster a Quality culture by educating and providing support to all Functional Areas in their use of and compliance with Quality System requirements.
• QA Consultant, Ciall Clinical Consultants, 04/01/24, 05/01/25, Provided consulting services across QMS improvement, SOP development, gap analysis, audit management, SOP write up, document reviews, deviations, CAPAs, and change controls management., Additional scope included Quality agreements support, GMP vendor qualification, Quality strategy and goal setting, and training oversight., Eventually converted to FTE with Alector.
• Clinical Phase I, Poseida Therapeutics (Cell/Gene Therapy Cancer), 01/01/19, 03/01/24, Responsible for Quality Management System (Document Control, Deviations, CAPAs, Change Control), audits/vendor management, training and validation., Lead developed and implemented Quality Management System (Electronic Management System) within 3 months., Lead effort in developing company SOPs from 16 legacy documents to over 400 effective SOP’s., Oversee audits and vendor management as they relate to cGMP compliance including CMO’s and vendors qualifications., Oversight of GMP Vendor Qualifications and Audits., Performing vendor sites audits., Responsible for assessing and approving Quality Agreements with CMOs and vendors to meet cGMP requirements and internal requirements., Manage, review, and approve deviations, exception reports, CAPAs and Change Controls in support of manufacturing issues., Review and approve manufacturing documents including master and executed batch records., Write, review, and approve SOPs, protocols, reports, and any other documents in support of Quality System., Responsible for implementing UL Compliance Learning Management System., Responsible for the development, execution, and maintenance of role-based training., Supported Quality Management Review Process and developed compliance Key Performance Indicators/metrics to trend the state of the quality system and drive improvements., Provide guidance to all company personnel on Quality System documentation requirements and strategy., Support quality assessments of internal operations to analyze compliance and assess risk., Develop, review, and approve proposed changes to systems, processes, and procedures., Support inspection readiness activities and provide SME support during regulatory inspections., Review new regulations within the pharmaceutical industry through literature review and professional conferences.
• Director of Corporate Quality Systems, Kite Pharma (a Gilead Company- Cell Therapy Cancer), 01/01/16, 12/31/19, Responsible for Quality Management System globally (Document Control, Deviations, CAPAs, Change Control)., Lead Quality Management System process and system improvements (Agile system Business Owner)., Implemented Quality Systems training program., The program significantly improved understanding by the Cell Therapy Specialist (CTS) in determining root causes and solutions development which lead to significant improvement in recurring and repeat deviations., Implemented improvements to compliance risks in Agile and data flow; added missing attributes critical to Quality., Ensure Quality Management System conformance to regulations and internal policies., Lead Monthly and Executive Quarterly Management Reviews., Revamped the metrics program to ensure critical to Quality Attributes were reported., Improved consistently in metrics and presentation requirements report out., Lead Global effort for Kite in the implementation of Next Generation Quality Management System (Veeva QualityDocs)., Oversee Deviation and CAPA system to ensure timely closure and effectiveness of investigations corrective and preventive actions., Global Quality Systems Lead at Kite for regulatory agency inspections., Support quality assessments of internal operations to analyze compliance and assess risk., Support external audits from vendors and CMOs., Review technical/Deviation/CAPA/investigation reports as appropriate., Develop, review, and approve proposed changes to systems and procedures.
• Sr. Manager, QA – Commercial Product (CMO Oversight), Gilead, 01/01/12, 12/31/16, Foster City, CA, Responsible for reviewing, assessing and approving batch records, deviations, CAPAs, and change controls from CMO’s., Quality Assurance lead for cross-functional teams including CMC, analytical, supply chain, and regulatory affairs., Work directly with operating entities (internal and CMOs) to ensure that commercial drug product operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, quality investigations and CAPA resolution for solid dose products., Participated in external commercial quality audits and represented Gilead during CMO site inspections by regulatory agencies., Review and approve Annual Quality Reviews., Create, review, and approve standard operating procedures to ensure alignment with industry and internal practices., Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews., Ensures compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Operational Excellence Principal at Roche for BBO Excellence Team (Global Role), Genentech- Roche, 01/01/12, 12/31/16, South San Francisco, CA, Responsible for performing analysis and recommendations on key business processes to enable the routine delivery of exceptional performance within the PTB, Pharma Tech Biologics and Process Excellence team., Provide recommended best options to Management based on business case and cost/benefit analyses., Partnered with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth., Use of LEAN Six Sigma (DMAIC) data-driven, problem-solving methodology to deliver tangible business results., Responsible for leading and participating in process improvement projects., Drive identification, measurement and realization of performance and change realization metrics., Provide expertise and build capability in LEAN /Six Sigma through execution of projects and mentorship for LSS Belts.
• Quality OE Leader, Genentech- Roche, 01/01/12, 12/31/16, South San Francisco, CA, Established appropriate 2013 goals and KPIs for SSFP Quality Leadership team to drive focus, urgency, accountability, and continuous improvement., Developed and managed scorecard for Genentech South San Francisco Quality leadership team., Discussed focus areas and plans to improve performance., Lead, managed, oversees, and coordinated various projects with Quality stakeholders related to Discrepancy Management, validation process and Change Control., On-going support to Quality organization on projects requests (workshops facilitation, metrics set up, guidance/strategy)., Provide expertise and build capability in LEAN /Six Sigma through execution of projects and mentorship., Lead the development of Human Prevention Deviations site strategy., Created tool for HEP Practitioner for assessments of deviations root cause classified as personnel.
• Master Black Belt (Global Role), Bayer Corporation, 01/01/06, 12/31/12, Berkeley, CA, Responsible for Management of multiple projects geared towards operations efficiencies, cost reductions, innovation, improvement of cycle times and safety enhancements in Europe, USA, Asia, and Latin America., Lead Adherence to lead time project to improve lot disposition reliability and efficiency to deliver planned & predictable performance., Executed supplier innovation initiatives (Dock to Stock indirect materials)., Continuous support and management of ERI projects savings information for BHC sites., Provide ongoing mentoring to Green Belts and Black Belts., Followed project governance model during project execution., Reduced inventories for Biotech product which contributed to the overall inventory to achieve value targets., Responsible for implementing BHC initiatives such as International Emerging Markets and T2M.
• Manager of Pharmaceutical Quality, Nektar Therapeutics, 01/01/05, 12/31/06, San Carlos, CA, Management of stage appropriate methods development and validation.
• Sr. Quality Manager, Microbiology and QC Manager, Baxter Healthcare Corporation, 01/01/00, 12/31/05, Fremont, CA, Responsible for the chemical, microbiological and/or physical quality assessments of raw materials, in-process and finished products., Responsible for metrology., Developed SOPs in accordance with CFR Part 11, 820, 210, 211, ISO 13485, 14971: 2012, 60601 regulations.
• QC Manager, QC and Calibration, Fusion Medical Technologies, 01/01/00, 12/31/02, Mountain View, CA, Responsible/ championing on execution of quality control and assurance within the department and across departments., Developed SOPs in accordance with CFR Part 11, 820, 210, 211, ISO 13485, 14971: 2012, 60601 regulations.
• Manager of QC Nutritional and OTC Division, ABCO Laboratories, 01/01/97, 12/31/00, Fairfield, CA, Responsible for Quality Control and Assurance.
• QC Microbiologist, ABCO Laboratories, 09/01/96, 06/01/97, Fairfield, CA
• Micro-Analysis Manager, National Chocolate Company, 08/01/91, 12/01/94

• CAR-TCR Summit
• Green & Black Belt Six Sigma Certified
• Statistical Method Data Analysis Minitab Training Root Cause Analysis Certified
• ADKAR Change Management PROSCI Certified
• CCL Strategic Leadership Program Principle Leadership in Action-PLA
• Women Leadership Program (Women Unlimited)
• Project Management Advanced