Manager Cold Chain Pharma

Benefits

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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, FedEx, K+N, Cardinal, McKesson, Cencora) Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note:

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