Senior Consultant – Supply Chain, GDP & DSCSA Compliance, Part-Time

Job Description: • 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. Requirements: • 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). Benefits: • Health insurance • 401K retirement savings plan (100% vested immediately in the employer match) • Paid time off for holiday, sick and vacation days • HSA • Wellness program • Flexible spending accounts • Tuition reimbursement • Employee Assistance program • Parental leave • Optional legal coverage and ID theft