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
Apply Now
Apply Now
• 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
Apply Now
Apply Now