Warehouse Operations Manager

Job Title Warehouse Operations Manager Department Supply Chain / Warehouse Operations Reports to Supply Chain Leader / Site Operations Leader Job Summary The Warehouse Operations Manager is responsible for all site warehousing, material handling, inventory control, production staging, and finished-goods fulfillment activities within a cGMP-regulated pharmaceutical manufacturing operation, including an FDA-registered 503B outsourcing facility. This role leads receiving, quarantine, storage, replenishment, issue, return, cycle counting, cold-chain operations, DEA-controlled-substance handling, and direct-to-customer pick, pack, and shipping. The position maintains secure, accurate, and traceable control of active pharmaceutical ingredients (APIs), excipients and other raw materials, batch-specific components, container-closure components, labels, packaging materials, consumables, quarantined and released inventory, returns, and finished drug products. The Manager ensures materials are stored under approved conditions, moved only through authorized processes, accurately transacted in approved systems, and issued or shipped only with the required status and authorization. This leader partners with Manufacturing, Quality Assurance, Quality Control, Supply Planning, Procurement, Pharmacy Operations, Regulatory Affairs, EHS, Security, Finance, Customer Service, Information Technology, carriers, couriers, and service providers. The role is accountable for safety, GMP compliance, controlled-substance security, inventory accuracy, order accuracy, warehouse productivity, and customer service. Responsibilities Warehouse Leadership and Daily Operations Lead warehouse supervisors, inventory-control personnel, material handlers, receivers, pickers, packers, and shipping personnel across assigned shifts. Establish daily staffing, workload priorities, shift handoffs, tiered accountability, escalation paths, and standard work for receiving storage, staging, and shipping. Ensure warehouse activities are performed safely, accurately, on time, and in compliance with approved procedures. Recruit, train, qualify, coach, and develop warehouse personnel; maintain effective succession and coverage plans. Maintain inspection-ready warehouse conditions, disciplined housekeeping, clear visual controls, and organized material flow. Develop contingency plans for labor shortages, storage constraints, equipment failures, temperature events, carrier disruptions, and urgent customer needs. GMP Receiving and Material Status Control Lead receipt, unloading, count verification, damage inspection, documentation review, system receipt, identification, and movement of incoming materials. Ensure incoming APIs, excipients, batch components, packaging materials, labels, consumables, and finished goods are placed in the correct quarantine or approved status and location. Maintain physical and electronic segregation of quarantined, sampled, approved, rejected, returned, expired, recalled, controlled, and awaiting-disposition materials. Coordinate sampling and inspection access with Quality Control and Quality Assurance while preserving identity, status, security, and environmental conditions. Ensure discrepancies, damage, contamination concerns, seal failures, temperature excursions, and documentation issues are promptly contained and escalated. Prevent use, movement, or shipment of materials that lack appropriate identity, status, release, or authorization. Storage of APIs, Excipients, Components, and Consumables Ensure APIs, excipients, raw materials, processing aids, filters, single-use assemblies, container-closure components, labels, packaging materials, cleaning supplies, PPE, and consumables are stored under approved conditions. Maintain accurate lot, quantity, location, status, expiration date, retest date, and storage-condition information throughout the material lifecycle. Apply first-expire, first-out practices where appropriate and control short-dated, expired, damaged, opened, partial, and obsolete inventory. Maintain segregation and controls for allergens, hazardous materials, sensitizing compounds, high-value materials, and other specially handled inventory, where applicable. Ensure racking, shelving, pallets, bins, containers, cages, and floor locations are safe, clean, identified, and suitable for their intended use. Monitor storage capacity and slotting and recommend layout, location, or workflow improvements. DEA-Controlled Substance Operations Manage warehouse activities involving DEA-controlled substances in partnership with the DEA registrant, Quality, Security, and authorized compliance personnel. Ensure controlled substances are received, stored, accessed, transferred, issued, returned, reconciled, shipped, and destroyed only under approved procedures and by authorized personnel. Maintain restricted-access storage, access lists, key or credential controls, surveillance interfaces, visitor controls, and documented chain of custody as applicable. Ensure controlled-substance records and inventories are complete, accurate, readily retrievable, and aligned with physical quantities and authorized transactions. Perform or support required inventories, routine reconciliations, discrepancy investigations, shipping documentation, destruction activities, and inspection readiness. Immediately escalate suspected theft, significant loss, diversion, tampering, unauthorized access, or unexplained discrepancies through established procedures. Ensure warehouse practices remain within the authority of the site DEA registration and applicable state controlled-substance licenses. Cold Storage and Temperature-Controlled Warehousing Lead operations for refrigerated, frozen, controlled-room-temperature, and other temperature-sensitive materials and finished products. Ensure receiving, put-away, staging, picking, packing, transfer, and shipping occur within approved conditions and allowable exposure times. Maintain response procedures for alarms, power losses, equipment failures, excursions, backup storage, and emergency product transfers. Partner with Quality, Engineering, Validation, and Metrology on mapping, monitoring, calibration, qualification, maintenance, and excursion investigations. Ensure temperature records, alarm responses, data loggers, shipping configurations, pack-out instructions, and chain-of-custody documentation are complete and retrievable. Minimize open-door time and time outside controlled storage through effective scheduling, staging, and workflow design. Production Material Staging and Returns Ensure accurate and timely picking and staging of APIs, excipients, batch components, labels, packaging materials, filters, single-use items, consumables, and cleaning supplies for manufacturing. Verify picks against approved production orders, bills of material, lot requirements, requested quantities, and Quality status. Maintain material identity, cleanliness, lot traceability, environmental control, and segregation during movement to and from production. Control partial containers, opened materials, dispensed materials, returns from manufacturing, excess quantities, damaged components, and reconciliation discrepancies. Coordinate line-side replenishment, supermarkets, kanban, and point-of-use inventory without weakening GMP or inventory controls. Monitor staging accuracy, shortages, late deliveries, returns, scrap, and recurring material-flow problems and implement corrective actions. Inventory Control and Traceability Own physical inventory accuracy for raw materials, APIs, excipients, components, consumables, packaging materials, controlled substances, and finished goods. Execute a risk-based cycle-count program, annual or periodic physical inventories, location audits, and controlled-substance reconciliations. Ensure ERP or warehouse-system transactions accurately reflect physical receipts, moves, issues, returns, adjustments, status changes, and shipments. Investigate discrepancies using structured root cause analysis and implement effective corrective and preventive actions. Monitor short-dated, slow-moving, excess, obsolete, rejected, blocked, damaged, and recalled inventory and coordinate timely disposition. Partner with Finance and Quality on inventory adjustments, reserves, period-end controls, destruction, audits, and record retention. Finished Goods and 503B Pick/Pack/Ship Lead finished-goods receipt, quarantine, released storage, order allocation, picking, independent verification, packing, documentation, carrier tender, and shipment confirmation. Ensure 503B products are shipped only after required Quality release and under approved customer, product, label, distribution, and order controls. Maintain lot-level and quantity traceability from finished goods receipt through direct shipment to hospitals, clinics, healthcare providers, and other authorized customers. Ensure approved requirements are followed for product selection, shipping labels, tamper evidence, cold-chain pack-out, data loggers, documentation, and customer-specific instructions. Manage shipping cutoffs, daily waves, labor capacity, order priority, holiday calendars, urgent orders, and service-level commitments. Ensure controlled-substance shipments use approved security controls, carriers, records, and authorized receiving parties as applicable. Manage proof of delivery, delivery exceptions, delays, temperature excursions, damage, refused shipments, returns, reshipments, and customer escalations. Maintain readiness to rapidly identify customer shipments by product, lot, quantity, date, and #J-18808-Ljbffr