Expert Details

Seasoned quality assurance and operations professional with over four decades of experience spanning plant operations, laboratory leadership, corporate auditing, and global quality system design. Career anchored in highly regulated environments including OTC drug products, medical devices, cosmetics, foods, and emerging categories such as CBD and microbiome-related products. Known for translating complex regulatory and corporate requirements into practical, sustainable systems that work at the shop-floor level. Brings a hands-on coaching approach that builds capability in individuals and teams while strengthening foundational systems. Combines risk-based thinking with deep operational insight to help sites achieve both compliance and competitive performance.

Quality and operational excellence leader with extensive experience across global CPG and healthcare product operations, including more than three decades with a leading multinational manufacturer. Background covers site operations, reliability engineering, laboratory and QA management, global audit program leadership, and independent consulting focused on quality capability building. Recognized for pragmatic, system-focused solutions that elevate compliance, reduce risk, and enhance organizational effectiveness.

• Deep expertise in quality assurance and operational leadership across highly regulated product categories

• Proven track record designing and deploying global quality systems and audit programs

• Hands-on coaching style that elevates individual, team, and site capability

• Strong understanding of FDA expectations and industry best practices for OTC drugs, medical devices, cosmetics, and foods

• Ability to translate complex quality and regulatory requirements into practical, sustainable shop-floor systems

• Experience standardizing quality approaches across diverse facilities, 3PL networks, and contract manufacturers

• Skill in using risk-based methods (including RPN) to prioritize audits and improvement efforts

• History of leading cross-functional teams through major system implementations, including SAP for QA

• Broad exposure to international operations and suppliers across multiple regions and regulatory environments

• Commitment to building strong operating cultures focused on ownership, accountability, and continuous improvement

• OTC drug products and pharmaceutical manufacturing environments

• Medical devices, healthcare products, and associated quality systems

• Cosmetics and personal care products (including hair care, deodorants, grooming)

• Food and beverage products, including snacks, beverages, and baby food

• CBD and hemp-derived product quality and emerging regulatory readiness

• Microbiome-related product quality for animal applications

• GMP and FDA-aligned quality systems for regulated products

• Quality systems for warehousing, customization, and 3PL operations

• Risk-based auditing and RPN-driven audit planning across global networks

• Complaint response systems and incident elimination processes

• Process control and reliability engineering approaches for manufacturing

• Supplier quality management and supplier capability development

• SAP implementation for quality assurance processes

• Corporate policies, SOP development, and standardization across plants and regions

• Principal, Independent Quality Consulting, LLC (2017–Present)

• Global QA Program Leader Go to Market Strategy for eCommerce, The Procter & Gamble Company, Cincinnati, OH (2004–2017)

• Corporate Audit Planning and Quality System Development Leader, The Procter & Gamble Company, Cincinnati, OH (2004–2017)

• Global Market Development Quality Assurance System Development Leader / Qualifying Auditor, The Procter & Gamble Company, Cincinnati, OH (2004–2017)

• United States Quality Assurance Leader – Customization and Warehousing, The Procter & Gamble Company, Cincinnati, OH (2004–2017)

• Principal Corporate Auditor – Global Customization, Warehousing, Snacks and Beverages, The Procter & Gamble Company, Cincinnati, OH (2004–2017)

• Secret, Sure, Old Spice Module QA Manager, The Procter & Gamble Company, Greensboro, NC (1998–2004)

• Quality Assurance SAP Implementation Leader, The Procter & Gamble Company, Greensboro, NC (1998–2004)

• Hair Care Styling Operations Manager (Making & Packing), The Procter & Gamble Company, Greensboro, NC (1998–2004)

• Plant Reliability Engineering Leader, The Procter & Gamble Company, Phoenix, AZ (1993–1998)

• Metamucil Making Operations Manager, The Procter & Gamble Company, Phoenix, AZ (1993–1998)

• Plant FDA Implementation Project Leader – Metamucil Quality Systems, The Procter & Gamble Company, Phoenix, AZ (1993–1998)

• Facility Operations and Utilities Manager, The Procter & Gamble Company, Norwich, NY (1982–1993)

• Packing Operations Manager – OTC and Prescription Products, The Procter & Gamble Company, Norwich, NY (1982–1993)

• Lab Chemist – Testing, Release, and Investigations, The Procter & Gamble Company, Norwich, NY (1982–1993)

• Led a global QA network to understand and address quality implications of direct-to-consumer and eCommerce markets, influencing package design, complaint response, and shipment strategy.

• Developed and managed a risk-based corporate audit planning approach for approximately 1,300 sites worldwide, using RPN to focus on the highest-risk operations.

• Provided oversight for development and management of quality systems for global warehousing and customization operations, serving as a qualifying auditor.

• Standardized quality systems across a broad network of U.S.-operated 3PL warehouses and customization sites, including during a major corporate integration.

• Coached, developed, qualified, and calibrated 28 business auditors around the globe while contributing to key corporate policies and SOPs.

• Managed multiple QA labs through an organizational redesign that improved throughput and daily operations for a 25-million-case-per-year business.

• Led QA implementation for SAP at the largest healthcare plant in a major CPG company, enabling more integrated and reliable quality processes.

• Directed making and packing operations for global non-aerosol hair care products, ensuring quality, throughput, and compliance.

• Led site reliability engineering and data-driven process improvement for plant throughput performance.

• Headed development and implementation of quality systems preparing a plant for potential FDA inspection linked to new product claims, contributing to improved systems across a network of six U.S. healthcare plants.

• Built quality and auditing capability for diverse external companies supplying regulated products and materials, including baby food, cosmetics, CBD products, and microbiome-related animal products.

• Provided targeted coaching on customer audit response and risk assessment for multiple suppliers and contract packagers.

BS, Chemistry, St. Lawrence University, Canton, NY (1982)

• Drove global risk-based audit planning for roughly 1,300 sites, significantly sharpening focus on high-risk operations and strengthening overall compliance.

• Elevated the capability of dozens of auditors, QA leaders, and site teams through structured coaching, qualification, and calibration, improving consistency of quality oversight.

• Standardized warehousing and customization quality systems across a large 3PL and internal site network, reducing variability and audit findings.

• Enabled plants and external partners to prepare effectively for FDA and customer audits, mitigating regulatory risk while maintaining business continuity.

• Designed and implemented practical, scalable quality systems for emerging and complex product categories, helping organizations enter and grow in regulated markets with confidence.