Strategic quality and regulatory leader with 15+ years of experience driving global QMS implementation and regulatory compliance across FDA-regulated, multi-site operations. Recognized for building high-performing teams, leading cross-functional initiatives, and delivering scalable process improvements that enhance audit readiness and operational efficiency.
Work History
Director, Quality and Regulatory Compliance
Thermo Fisher Scientific
Fremont, California
07.2022 - Current
Build and elevate high-performing talent pipelines by mentoring cross-functional teams and articulating a clear internal value proposition that aligns with individual growth and business objectives.
Steer a >$15 million annual operating budget - prioritizing business needs and resource allocations to deliver up to a high of 18% cost savings.
Guide the QA/RA organization through complex transformations, safeguarding day-to-day execution and keeping stakeholders focused on long-term strategic targets that drove efficiency increases of 20%.
Strengthen process controls to ensure global regulatory compliance, achieving zero major findings in three notified body audits.
Champion a culture of engagement and collaboration through targeted recognition, transparent communication, and career-development initiatives, boosting employee engagement results year-over-year to above company average by 10%-15%
Embed continuous-improvement by launching a Quality GEMBA program aligned with enterprise process initiatives, driving 10 kaizen events and achieving >40% reduction in deviations, >25% in OOS, and 20% in product nonconformance.
Vice President, Quality Assurance and Regulatory Affairs
Fluidigm Corporation
South San Francisco, California
10.2017 - 07.2022
Promoted from Sr. Director, QA/RA in June 2021
Led regulatory submissions and launches of two IVD products (2020, 2021), ensuring full compliance with applicable standards and accelerating market entry.
Directed cross-functional teams and partnered with senior leadership to execute strategic initiatives, resulting in new product launches, improved efficiency, and customer satisfaction.
Built and nurtured strong relationships with regulators, customers, suppliers, and stakeholders to support compliance, collaboration, and business growth.
Established a culture of quality and continuous improvement, driving innovation, sustainable operations, and organizational agility.
Implemented automated QMS workflows and streamlined processes, increasing productivity and delivering measurable cost savings.
Ensured proactive regulatory compliance through robust internal controls, risk-based monitoring, and deep understanding of global regulatory frameworks.
Director of Quality and Regulatory
Expression Systems
Davis, California
04.2015 - 10.2017
Set enterprise quality and regulatory strategy for cell-culture media and baculovirus reagent lines, aligning operations with FDA 21 CFR 210/211 and 21 CFR 820 to support growth across pharma, IVD, and academic markets.
Led cross-functional QMS governance, providing oversight of CAPA, change control, supplier management, and audit programs; drove a right-first-time culture that reduced deviations and findings.
Initiated and executed digital-quality roadmap. Selected, project-managed, and completed full implementation and Computer System Validation (CSV) for a new electronic QMS and equipment asset management system, delivering on schedule and boosting data integrity and audit readiness.
Championed risk-based compliance, integrating GxP best practices across manufacturing, QC, and logistics to enhance process capability and shorten release timelines.
Director of Quality
Biosearch Technologies
Novato, California
04.2010 - 04.2015
Led all Quality functions (QA, QC, Validation, Engineering, and Metrology) for a global contract manufacturer of oligonucleotides and specialty reagents produced as components of IVD tests.
Directed validation strategy and execution for enterprise systems, including internally developed eQMS and Oracle eBusiness Suite, delivering compliant, audit-ready digital infrastructure.
Successfully led the company through initial ISO 13485 certification with zero findings, while building high-performing teams and driving a culture of continuous improvement and audit readiness.
QA/QC Supervisor II
Bio-Rad Laboratories
Hercules, California
09.2008 - 03.2009
Quality Manager
AcroMetrix Corporation
Benicia, California
04.2003 - 09.2008
Education
Master of Science - Biology
University of Nebraska At Kearney
Kearney, NE
05.2009
Bachelor of Science - Biochemistry
University of California, Davis
CA
06.2001
Affiliations
Member, American Association for the Advancement of Science (AAAS) 2006 – present
Member, American Society for Quality (ASQ) 2006 – present
Member, Association for Molecular Pathology 2006 – 2010
Competencies
Regulatory Mastery: Deep expertise in 21 CFR 820, MDSAP, ISO 13485, ISO 14971; proficient in interpreting and applying global regulatory standards across product lifecycles
Quality Systems Excellence: Leadership in building, scaling, and maintaining robust Quality Management Systems (QMS); strong command of design control, design assurance, V&V, risk management, and lifecycle documentation
Audit & Compliance Oversight: Extensive experience leading internal, external, and supplier audits; CAPA management; inspection readiness; and regulatory body engagement (FDA, DEA, Notified Bodies)
Strategic & Operational Leadership: Visionary leader with a track record of aligning quality and regulatory strategy with business goals; drives process optimization and compliance culture across matrixed, global organizations
Cross-Functional Collaboration: Skilled in cultivating strong partnerships across R&D, manufacturing, regulatory, and executive teams to enable compliant innovation and sustained product quality
Data-Driven Decision Making: Champion of continuous improvement through metrics, risk-based approaches, and data analytics for informed, impactful decisions
Director Global Quality and Regulatory Compliance at Nature's Sunshine ProductsDirector Global Quality and Regulatory Compliance at Nature's Sunshine Products
<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC
<ul>
<li>Hours per week: 40.</li>
</ul>
<p><strong>Duties, Accomplishments, and Related Skills:</strong></p>
<ul>
<li>Supervise and coordinate daily administrative workflows for a team of 15 employees, ensuring timely task execution, adherence to protocols, and consistent performance monitoring.</li>
<li>Maintain accurate records and documentation related to property intake, detainee processing, transportation, and deportation; verify and audit files to ensure regulatory compliance, and data integrity.</li>
<li>Execute high-volume data entry (up to 8 hours per day), including the entry of case notes, customs documentation, custody logs, and internal reports into secure federal databases.</li>
<li>Develop, review, and edit administrative reports and forms for internal use and government audits; ensure completeness, accuracy, and policy alignment.</li>
<li>Serve as the primary liaison between facility staff, supervisors, and stakeholders; facilitate clear, professional communication, and documentation flow across departments.</li>
<li>Identified discrepancies in data entries and corrected them accordingly.</li>
<li>Oversee inventory control processes, including the secure receipt, tracking, and storage of personal property, using standardized procedures and government tracking systems.</li>
<li>Conduct routine audits and quality control reviews to ensure that administrative practices meet federal operational standards.</li>
<li>Apply sound judgment to evaluate options, solve problems, and make informed recommendations on administrative and operational matters, contributing to efficient workflow management, and compliance with agency standards.</li>
<li>Assist in developing and revising privacy and security policies concerning Personally Identifiable Information (PII); identify potential compliance risks, and recommend solutions.</li>
<li>Coordinate logistics for detainee transportation to court and medical appointments, manage schedules, and track movement through detailed administrative planning.</li>
<li>Conduct roll calls, and ensure accountability through diligent documentation, system updates, and status reporting.</li>
</ul>
<p>Supervisor: Scott Jackson (949) 456-2706.</p>
<p>Permission to contact: Yes.</p> at ProTech USA LLC, Government Contracting<ul>
<li>Hours per week: 40.</li>
</ul>
<p><strong>Duties, Accomplishments, and Related Skills:</strong></p>
<ul>
<li>Supervise and coordinate daily administrative workflows for a team of 15 employees, ensuring timely task execution, adherence to protocols, and consistent performance monitoring.</li>
<li>Maintain accurate records and documentation related to property intake, detainee processing, transportation, and deportation; verify and audit files to ensure regulatory compliance, and data integrity.</li>
<li>Execute high-volume data entry (up to 8 hours per day), including the entry of case notes, customs documentation, custody logs, and internal reports into secure federal databases.</li>
<li>Develop, review, and edit administrative reports and forms for internal use and government audits; ensure completeness, accuracy, and policy alignment.</li>
<li>Serve as the primary liaison between facility staff, supervisors, and stakeholders; facilitate clear, professional communication, and documentation flow across departments.</li>
<li>Identified discrepancies in data entries and corrected them accordingly.</li>
<li>Oversee inventory control processes, including the secure receipt, tracking, and storage of personal property, using standardized procedures and government tracking systems.</li>
<li>Conduct routine audits and quality control reviews to ensure that administrative practices meet federal operational standards.</li>
<li>Apply sound judgment to evaluate options, solve problems, and make informed recommendations on administrative and operational matters, contributing to efficient workflow management, and compliance with agency standards.</li>
<li>Assist in developing and revising privacy and security policies concerning Personally Identifiable Information (PII); identify potential compliance risks, and recommend solutions.</li>
<li>Coordinate logistics for detainee transportation to court and medical appointments, manage schedules, and track movement through detailed administrative planning.</li>
<li>Conduct roll calls, and ensure accountability through diligent documentation, system updates, and status reporting.</li>
</ul>
<p>Supervisor: Scott Jackson (949) 456-2706.</p>
<p>Permission to contact: Yes.</p> at ProTech USA LLC, Government Contracting
<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.