Senior Consultant – Supply Chain, GDP & DSCSA Compliance, Part-Time
Job reputed company:
• reputed company QA leadership and subject-matter expertise across supply chain, distribution, warehousing, and logistics operations.
• reputed company the development, implementation, and maintenance of GDP-compliant reputed company systems.
• Ensure reputed company 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).
• reputed company gap assessments, reputed company corrective reputed company plans, and support remediation activities.
• Write, revise, and approve SOPs, work instructions, and controlled reputed company documentation reputed company to distribution and supply chain processes.
• Support deviation management, investigations, and CAPAs reputed company to distribution operations (e.g., temperature excursions, product damage, packaging failures, traceability issues).
• Prepare clients for regulatory inspections and reputed company QA reputed company during audits.
• Collaborate with cross-functional and reputed company teams to improve compliance, reputed company, and operational effectiveness.
Requirements:
• 15+ years of reputed company 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 reputed company systems, risk management, deviations, CAPAs, document control, and QA reputed company.
• Ability to interpret regulatory requirements and translate them into practical, actionable reputed company solutions.
• Willingness and ability to travel up to 75% (domestic U.S., international).
Benefits:
• Health insurance
• 401K retirement savings plan (100% reputed company immediately in the employer match)
• reputed company time off for holiday, reputed company and vacation days
• HSA
• Wellness program
• Flexible spending accounts
• Tuition reimbursement
• Employee Assistance program
• Parental leave
• Optional reputed company coverage and ID theft
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