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 (28C 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 endtoend pharmaceutical cold chain distribution ensuring compliance with GDP and GMP requirements for temperaturecontrolled 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 daytoday 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

• Bachelors 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 KN 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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time