Provide QA leadership and subject-matter expertise across supply chain, distribution, warehousing, and logistics operations.
Lead the development, implementation, and maintenance of GDP-compliant quality systems.
Ensure client readiness and ongoing adherence to DSCSA requirements, including serialization, verification, and trading partner compliance.
Conduct comprehensive GDP and DSCSA audits of distribution centers, 3PLs, transportation providers, and supply chain vendors (on-site and remote).
Perform gap assessments, develop corrective action plans, and support remediation activities.
Write, revise, and approve SOPs, work instructions, and controlled quality documentation related to distribution and supply chain processes.
Support deviation management, investigations, and CAPAs related to distribution operations (e.g., temperature excursions, product damage, packaging failures, traceability issues).
Prepare clients for regulatory inspections and provide QA oversight during audits.
Collaborate with cross-functional and client teams to improve compliance, quality, and operational effectiveness.

15+ years of Quality Assurance experience in pharmaceuticals, biotechnology, or medical devices.
Strong expertise in Good Distribution Practices (GDP) and global distribution compliance expectations.
Proven experience with DSCSA, including serialization, EPCIS data exchange, verification processes, and trading partner requirements.
Extensive experience conducting audits of distribution facilities, warehousing operations, and logistics providers.
Deep understanding of GxP quality systems, risk management, deviations, CAPAs, document control, and QA oversight.
Ability to interpret regulatory requirements and translate them into practical, actionable quality solutions.
Willingness and ability to travel up to 75% (domestic U.S., international).

Senior Consultant – Supply Chain, GDP, DSCSA Compliance

Key skills