Manager Cold Chain Pharma

Manager Cold Chain Pharma

Strategic pharmaceutical trade and distribution professional with expertise in compliant commercialization and distribution operations for temperature-sensitive drug products. Proven ability to establish and manage state licensing, DSCSA and trade compliance requirements, and operational distribution networks across wholesalers, specialty distributors, and 3PL partners. Strong cross-functional partner to Quality, Regulatory, Supply Chain, Product Launch, and Supply Planning teams in highly regulated pharmaceutical environments, ensuring compliant, reliable, and scalable product distribution across markets.

Pharmaceutical Cold Chain Expertise

• GDP / GMP / GxP Compliance
• Cold Chain Distribution (2–8°C, CRT, Frozen)
• Temperature Excursion Management & CAPA
• Validated Lanes & Packaging Systems
• Pharmaceutical DC Operations
• Audit Readiness & Regulatory Inspections
• Deviation Documentation & QA Collaboration
• 3PL / Freight Forwarder Oversight
• Change Control & Network Transitions
• Product Integrity & Patient Safety Focus
• Support establishing and maintaining state licensing

Essential Job Duties

• Manage end-to-end pharmaceutical cold chain distribution, ensuring compliance with GDP and GMP requirements for temperature-controlled drug products.
• Oversee validated shipping lanes and packaging solutions (passive and active), ensuring product integrity from release through patient delivery.
• Lead temperature excursion investigations, including deviation documentation, root cause analysis, CAPA development, and Quality approvals.
• Partner closely with Quality Assurance and Regulatory Affairs to maintain audit readiness and support internal and external inspections.
• Ensure accurate and complete shipment documentation, traceability, and data integrity in accordance with regulatory expectations.
• Manage day-to-day operations across distribution centers, 3PLs, and carriers, resolving issues while maintaining compliance.
• Support network changes, product launches, and fulfillment transitions through risk assessments, validation activities, and change control.
• Monitor carrier and 3PL KPIs related to temperature performance, OTIF, and deviation trends.
• DSCA, state distribution licenses, wholesale distribution authorization
• Trade Compliance Import/Export

Success Metrics

• Maintain reportable temperature deviations below 1% through improved monitoring and SOP enhancements.
• Maintained zero critical audit findings across GDP inspections.
• Supported commercial and clinical product launches with 100% cold chain compliance.
• Improved cold chain OTIF performance to >99% while maintaining validated conditions.

Required Skills and Experience

• Bachelor's Degree – Supply Chain, Life Sciences, Engineering, or Business
• 8+ years of experience in pharma supply chain management
• Coordinated domestic and international pharmaceutical shipments require strict temperature control.
• Assisted in lane qualification and packaging validation activities.
• Supported Quality in deviation reporting, CAPA tracking, and audit preparation.
• Tracked carrier performance and temperature data to identify risk trends.
• Maintained SOPs and work instructions aligned to GDP requirements.
• Build and maintain relationships with pharmaceutical wholesalers and specialty distributors.
• GDP (Good Distribution Practice) Training
• GMP Training
• APICS CPIM / CSCP (Preferred)
• Six Sigma Green Belt (Optional)

Pharmaceutical Systems & Tools

• Temperature Monitoring & Data Logger Platforms
• Deviation & CAPA Management Systems
• Validated Passive & Active Shipper Systems
• TMS / WMS (SAP, Oracle, Manhattan, etc.)
• Carrier, Distributor and Wholesaler Platforms (DHL Life Sciences, UPS Healthcare, Fed Ex, K+N, Cardinal, McKesson, Cencora)