San Diego, California, United States
Accomplished manufacturing, quality, supply chain, and operations leader with extensive experience in biotech and healthcare, combining expertise in site management, manufacturing, quality assurance programs, and business development. Known for driving process optimization and continuous improvement while fostering high-performing, cross-functional teams. Skilled at strategic planning, organizational development, and embedding lean and Shingo-based practices to enhance efficiency and deliver business value. Adept at leading complex initiatives, including site expansions, consolidations, and regulatory compliance, with a strong ability to align operational and supply chain capabilities with corporate strategy. Recognized for building talent pipelines and developing leaders across multiple disciplines, translating technical and operational expertise into sustainable organizational impact.
● Lead dual-site operations with teams ranging from 60 to 135 staff, spanning manufacturing, warehouse, quality, and process improvement functions. ● Direct end-to-end operations for TMA assays, PCR cartridges, and lateral flow assays, generating high-value product lines while maintaining regulatory compliance. ● Build and mentor a 20-person leadership bench, strengthening succession planning and cross-functional collaboration. ● Rapidly scaled production during the COVID-19 pandemic to meet urgent testing demand, ensuring strict compliance with regulatory standards and maintaining high-quality outputs under accelerated timelines. ● Oversee multi-site consolidation and technology integration, streamlining operations and improving throughput. ● Leveraged Shingo-based operational excellence and lean initiatives to embed a culture of accountability, driving team lean belt certification from 0% to 85%, achieving a 2.5% annual cost reduction, and scaling continuous improvement projects from 10 to over 450 per year. ● Partnered with Finance, Supply Chain, and cross-functional teams to optimize forecasting, budgeting, and resource allocation for a product generating $1.2B in annual revenue, ensuring alignment of operational strategy with business goals. ● Support corporate growth strategies through M&A due diligence and co-development of the M&A playbook, enhancing acquisition integration planning.
● Managed a 19-member QA team, overseeing inspection, product release, MRB, CAPA, and compliance. ● Expanded continuous improvement initiatives from 10 to 56 annually, improving quality system efficiency. ● Drove QA excellence by scaling continuous improvement projects 5x, achieving $500K in operational savings, and embedding metrics and dashboards to sustain compliance with FDA and global audit standards. ● Led high-stakes initiatives across functions including $1M GMP remediation, critical material rebranding, and risk management automation, while designing growth programs that elevated team performance in a regulated diagnostics setting. ● Developed robust compliance and training programs, sustaining FDA and global regulatory audit readiness. ● Led cross-functional projects including GMP remediation, critical material rebranding, and Risk Management Program automation. ● Introduced structured career development programs for QA staff, enhancing retention and leadership growth.
● Supported a team of 8 Quality Engineers supporting new product introduction, supplier quality, process improvement, and risk management. ● Developed and implemented a risk-based process validation program across multiple manufacturing sites. ● Strengthened regulatory compliance with FDA, CDRH, and CBER standards while supporting audits and cross-functional improvement initiatives.
● Delivered validation consulting services for biotech and pharmaceutical clients, ensuring compliance with FDA, cGMP, and ISO standards. ● Partnered with client teams to execute IQ/OQ/PQ protocols, accelerating project timelines and regulatory approvals. ● Founded and developed a new San Diego branch, growing the team from 0 to 8 employees and driving annual sales of $3.5M while expanding service contracts and supporting overall revenue growth. ● Advised cross-functional teams on risk mitigation, operational excellence, and regulatory readiness.
● Performed microbiological testing and QC for pharmaceutical products, ensuring FDA and cGMP compliance. ● Supported aseptic processing, environmental monitoring, and nonconformance investigations. ● Collaborated with manufacturing and QA teams to support product release, validation, and audit readiness.
● Performed microbiological testing and QC for pharmaceutical products, ensuring FDA and cGMP compliance. ● Supported aseptic processing, environmental monitoring, and nonconformance investigations. ● Collaborated with manufacturing and QA teams to support product release, validation, and audit readiness.