Irvine, California, United States
Hi! Welcome to my profile: As a Senior Project Manager with more than 10 years of experience in medical device and biotechnology environments, I specialize in leading complex product development, portfolio management, and process improvement initiatives that drive business results while maintaining compliance in highly regulated industries. My career has been built around partnering with cross-functional teams across R&D, Regulatory Affairs, Quality, Clinical Operations, Manufacturing, Marketing, and Executive Leadership to bring strategic initiatives from concept through commercialization. I thrive in matrixed organizations where success depends on collaboration, stakeholder alignment, disciplined execution, and the ability to influence without direct authority. Key areas of expertise include: • New Product Development (NPD) • Portfolio & Program Management • Project Governance & Stage-Gate Processes • PMO Process Improvement • Design Controls & Regulatory Compliance • Risk Management & Mitigation • Strategic Planning & Resource Management • Cross-Functional Leadership • Continuous Improvement Initiatives My signature achievements are the following: ➤ Established end-to-end Product and Portfolio Management frameworks supporting strategic decision-making for New Product Development initiatives. ➤ Spearheaded the redesign of a Stage-Gate governance process, improving project prioritization, review, and approval workflows. ➤ Launched a Quality Systems continuous improvement program that strengthened collaboration, governance, and operational excellence. ➤ Expanded participation in a global Innovation forum from approximately 70 employees to more than 700 employees across multiple functions and departments. ➤ Led cross-functional teams through complex product development and operational initiatives while balancing scope, schedule, risk, quality, and compliance requirements. I am passionate about building scalable processes, driving organizational alignment, and helping teams successfully navigate complexity to deliver meaningful outcomes for patients, customers, and the business.
Established end-to-end project and portfolio management frameworks to enable strategic alignment and data-driven trade-off decisions for New Product Development (NPD) initiatives. Led key initiatives to enhance process efficiency and strengthen regulatory compliance. Key deliverables included: ◆ Led development of project charters, project management plans, governance reviews, and portfolio prioritization frameworks for New Product Development programs, ensuring alignment with organizational objectives and strategic priorities. ◆ Developed and managed project plans, schedules, and interdependencies for multiple concurrent initiatives, ensuring timely execution and delivery. ◆ Directed project execution through all phases of the product development lifecycle, monitoring progress, managing changes, and balancing scope, schedule, resources, quality, and business objectives. ◆ Facilitated cross-functional team meetings, governance reviews, and stakeholder communications to drive accountability, resolve obstacles, and ensure successful execution against project goals. ◆ Developed PMO templates, governance processes, reporting tools, and standardized project management methodologies that improved execution consistency, transparency, and organizational project maturity. ◆ Collaborated in the development and implementation of Design Control and Stage-Gate processes, standardizing workflows, templates, training materials, and governance structures to ensure regulatory compliance and process adherence.
The following were my day-to-day duties in this job position: Directed end-to-end resource planning, capacity management, and tracking across high-impact programs, enabling leadership to make portfolio-level trade-off decisions for New Product Development (NPD) through strategic alignment and data-driven insights. Served as primary system administrator for PD Ware, Smartsheet, and SAP SuccessFactors Employee Central, ensuring accuracy of enterprise resource and training data. Enabled decision-making and real-time training compliance visibility by developing KPI dashboards and presenting steering committee materials to executive leadership. Key Deliverables were: ◆ Monitored portfolio performance through KPI tracking and executive-level reporting, providing data-driven insights that informed investment decisions, resource allocation, and portfolio prioritization. ◆ Directed and coordinated multiple cross-functional projects simultaneously, managing scope, schedules, resources, and deliverables while ensuring compliance with Design Control, quality, and regulatory requirements. ◆ Led enterprise-wide implementation of Design Control training for more than 500 employees by developing deployment plans, coordinating resources, managing training logistics, and tracking completion metrics through SAP SuccessFactors. ◆ Developed training governance, performance metrics, and adoption tracking processes to support organizational readiness and consistent execution of the new Design Control framework across multiple business functions. ◆ Received the Spotlight Award for exceptional cross-functional leadership and execution excellence in successfully delivering the Clinical Diagnostic Group's enterprise-wide Design Control Training Program in 2024.
While serving as Project Manager II, I supervised Agile-based legacy software teams to promote continuous deployment and enhance cooperation between development and quality assurance groups. Overseeing complete project lifecycles, I managed updates to standard operating procedures, conducted validations, and prepared for audits to ensure regulatory compliance. Facilitated multiple cross-departmental projects focused on accelerating turnaround times, minimizing expenses, and refining internal processes within regulated manufacturing sectors. Through effective project oversight, I streamlined workflows while ensuring full compliance with industry regulations. Assuming responsibility for compliance initiatives, I guaranteed that all documentation and protocols were audit-ready and aligned with quality standards. Key Deliverables were: ◆ Enhanced operational consistency by standardizing documentation, implementing centralized tracking tools, and coaching teams on Good Documentation Practices (GDP). ◆ Strengthened audit readiness by ensuring documentation integrity and compliance with FDA and ISO standards by minimizing findings during internal and external audits. ◆ Generated over $1M in annual savings, delivered process improvement initiatives, such as plasma consolidations and alternate viral inactivation, and reduced cycle time. ◆ Received Spotlight Award for launching Ideation and Innovation Program within Quality System Division and scaling it to Clinical Diagnostic Group (CDG) in 2021.
My responsibility was to spearhead the creation of project roadmaps and aided business unit planning by pinpointing opportunities for improvement and aligning Continuous Improvement (CI) initiatives with organizational objectives. Implementing Lean principles throughout manufacturing operations, I managed updates to standard operating procedures, enhanced documentation, and drove standardization efforts. Supporting strategic goals, I identified key areas for process enhancement and coordinated efforts to embed Lean methodologies across departments. Taking charge of CI activities, I fostered collaboration among teams to achieve measurable improvements in efficiency and quality. Key Deliverables were: ◆ Boosted process governance and execution consistency by standardizing milestones for Non-NPD (New Product Development) projects. ◆ Launched centralized Line Side Dispensary system in manufacturing by saving over $100K annually and enhancing efficiency and mistake-proofing. ◆ Launched and led a new Continuous Improvement team tasked with driving cross-functional process optimizations and advancing operational excellence. ◆ Exceeded $150K per year for cost savings through streamlined Value Assignment labeling processes initiative. ◆ Improved visibility into CI initiatives by tracking team metrics and coordinating quality improvement projects across operational units.