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Susan Sandoval

VICE PRESIDENT OF QUALITY/ HR DIRECTOR

Self-directed and goal-oriented Quality professional with 20 years of experience in positions of increasing levels of responsibility. Sue demonstrates strong skills in organization, change management, communications, and program management. Effectively delivers results leveraging experience from working in diverse teams. Established leader demonstrated by empowerment, consistency, and continuous improvement. She earned her B.S. degree from California Polytechnic State University.

  • Extensive experience working with all cGMP Quality Programs: NC/ CAPA, Change Control, Facility/ Process Validation, Batch Record Review/ Lot disposition, Environmental and High Purity Water Monitoring Programs.

  • Provides Quality Assurance oversight during regulatory agencies (FDA/ EMA) pre-licensure and biennial inspections.

  • Product Disposition Manager responsible for all aspects of Disposition Decision, Documents, and Validation review and approval.

  • Streamlined the Commercial Bulk Lot release approval process and maintained 100% on time product release rate.

  • Extensive experience investigating, writing, reviewing and approving non-conformances related to all aspects of pharmaceutical commercial bulk drug substance production.

  • Managed Engineering Change Control Process and Engineering Business Practices.

  • Developed, updated, and maintained engineering document templates to support commissioning, change control, and quality management as a Subject Matter Expert (SME).

  • Developed training programs and train clients on engineering programs.

  • Provided CMMS Planning and Scheduling Tools/ Training.

  • Provided Quality oversight of Engineering and Manufacturing processes.

  • Extensive experience investigating, writing, reviewing and approving non-conformances related to all aspects of pharmaceutical bulk drug substance production.

  • Authored and presented responses to regulatory audit inquiries regarding commissioning, validation, and maintenance procedures.

  • Created and owned validation, commissioning non-conformance (deficiency) tracking tool with responsibility to report metrics and follow up on closure of items.

  • Created and managed Commissioning/ Validation Document Control libraries (electronic and hard copy).

  • Managed Turn Over Package deliverables, receipt, and reconciliation from vendors.

  • Developed and managed server-based Microsoft Project and Primavera Schedules on biopharmaceutical projects for Commissioning, Validation, and QC Analytical Method Transfer to a newly constructed facility.

  • Lead project update meetings to track progress on scheduled activities and to mitigate delays for items tracking as late.

  • Run Production Line Deep Dive meetings to resolve timeline issues caused by construction delays or inter-department confusion for a new biopharmaceutical manufacturing facility.

  • Develop SharePoint sites for inter-department and inter-organizational collaboration amongst project teams.

  • Manage, maintain, and train on SharePoint Systems.

  • Project Manager for Commissioning and Validation of facility utility systems on a new manufacturing facility.

  • Execute Commissioning and Validation protocols.

  • Project Manager on QP Audit for cell therapy/ T-Cell/ CAR T treatment filing, including scheduling and managing one year of audit response activities.

  • Project Manager QP Audit prep including scheduling of audit training/ prep sessions and execution of Mock Audits.

  • Project Manager for PAI Readiness for cell therapy/ T-Cell/ CAR T treatment filing.

  • Develop schedule for PAI Readiness prep and review FDA PAI Readiness checklists with department leads.

  • Project Manager on 3 Phases of PPQ execution for cell therapy/ T-Cell/ CAR T treatment filing.

  • Project Manager on facility shutdown for HEPA Certification and EMPQ, Media Simulations.

  • Set up Key Performance Indicators and resource tracking based off integrated schedules. 

  • Develop schedules and reporting to address and reduce the backlog of manufactured cell therapy/ T-Cell/ CAR T lots that require specific QC assays to be executed in order to release.

  • Schedule Lot disposition activities required to release cell therapy/ T-Cell/ CAR T lots for clinical and commercial use.

  • Prepare and update slide decks for management and executive-level status reporting.

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