Job Description
Manager Cold Chain Pharma Intuitive Surgical•3.7 Sunnyvale, CA Job Details $115,700•$195,900 a year 14 hours ago Qualifications Quality control corrective actions Export management Regulatory inspections Customs regulations compliance Temperature-controlled storage Procedural guides Supply chain risk management Shipment tracking for distribution operations Drug regulation Production deviation management Cold chain logistics Corrective and preventive actions (CAPA) Manufacturing standard operating procedures Data integrity and documentation Quality risk management Packaging Distribution management Temperature monitoring Logistics vendor relationship management Perishable goods transportation Refrigerated goods transportation Standard operating procedures (SOPs) International trade regulations Audit support Full Job Description Sunnyvale, CA, United States Not Remote Manufacturing & Operations
JOB215424
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surger y and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide. Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life. If you're ready to contribute to something bigger than yourself and help transform the future of healthcare , you'll find your purpose here. Job Description 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. Qualifications 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) Additional Information 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: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed. Base Compensation Range Region 1: $136,100 USD•$195,900 USD Base Compensation Range Region 2: $115,700 USD•$166,500 USD Shift:
Day Workplace Type:
Onsite•This job is fully onsite.
