Manager Cold Chain Pharma

Intuitive•Sunnyvale, CA

About The Position

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.

Requirements

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

Nice To Haves

APICS CPIM / CSCP (Preferred)
Six Sigma Green Belt (Optional)

Responsibilities

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