Interim & Fractional Quality Leadership
Bridge coverage as VP/Director of Quality during a transition, leave, or search, keeping audit readiness and document control on schedule.
Continuous Improvement
Root cause analysis and DMAIC-driven process improvement to reduce rework, waste, and non-conformances without slowing production.
Quality System Integration for M&A
Harmonizing SOPs, specifications, and quality management systems across newly combined organizations, with continuity of supply as the priority.
Vendor & Supplier Quality Programs
Risk-based vendor approval programs and incoming-material testing protocols built to hold up under GFSI, USDA and FDA scrutiny.
HACCP, HARPC & Food Safety Plans
Hazard analysis and food safety plan development and validation under both HACCP and HARPC (FSMA Preventive Controls) frameworks, for new products, new lines, and new facilities.
Dietary Supplement GMP & Sport Certification
GMP and NSF/ANSI 455-2 (GMP for Sport) audit preparation, including botanical and vitamin ingredient identity and potency testing strategy.
GFSI Certification Readiness
Gap assessments, documentation build-out, mock audits, and corrective-action support to get a new site certified or keep an existing certification on track, including transition support to the newest scheme editions such as SQF Edition 10 and BRCGS Issue 9.
USDA/FSIS & TTB Regulatory Compliance
Gap assessment, label review, and audit prep for USDA/FSIS-inspected meat and ready-to-eat production, plus TTB-regulated alcohol beverage labeling. On-site USDA inspector coordination and Certificate of Label Approval (COLA) filing support.
FDA Regulatory Compliance & Audit Readiness
Gap assessment and preparation against dietary supplement GMP, low-acid and acidified food processing, preventive controls, and food defense. Documentation review and mock FDA inspections.
Equipment Qualification & Validation
Equipment qualification protocols (IQ/OQ/PQ) with recommended validation and verification testing, preventive maintenance schedules, and sanitation schedules, plus the SOPs and forms to support them.
Quality Organization Build-Out
Standing up a quality department from the ground up: role architecture, KPI frameworks, document control systems, and audit-readiness cadence.

