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 elevate 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 destination for investigations and recalls. Warehouse Systems, Equipment, and Facilities Ensure effective use of ERP, warehouse management, barcode, scanning, label-printing, shipping, carrier, and inventory systems. Maintain transaction discipline, user access, data accuracy, master-data escalation, system backups or contingencies, and controlled label use. Ensure forklifts, pallet jacks, scales, scanners, printers, dock equipment, racking, refrigerators, freezers, and monitoring devices are maintained, inspected, calibrated, or qualified as applicable. Coordinate repairs and preventive maintenance with Engineering, Facilities, Metrology, IT, and service providers while protecting inventory and business continuity. Control warehouse access, doors, cages, docks, visitor entry, and after-hours activities in partnership with Security. Develop equipment, space, and capital plans to support safe operations, storage capacity, productivity, and compliance. Quality Systems and Inspection Readiness Ensure warehouse operations comply with cGMP, GDP, data-integrity expectations, approved procedures, DEA requirements, applicable state licenses, and company policies. Author, review, and maintain warehouse SOPs, work instructions, forms, training materials, risk assessments, deviations, CAPAs, and change controls. Lead or support investigations involving inventory discrepancies, incorrect picks, shipping errors, temperature excursions, damaged product, unauthorized access, and controlled-substance events. Partner with Quality on material status, sampling, release, rejection, returns, recalls, destruction, and distribution records. Represent warehouse operations during FDA, DEA, state, customer, and internal inspections or audits. Ensure observations, commitments, and CAPAs are technically sound, completed on time, and effective in preventing recurrence. Safety, Security, and Continuous Improvement Maintain safe practices for receiving docks, trailers, forklifts, pallet movement, lifting, racking, cold storage, hazardous materials, spills, and waste handling. Ensure personnel are trained and qualified for assigned GMP, safety, security, controlled-substance, cold-chain, and shipping responsibilities. Use visual management, standard work, 5S, daily metrics, and structured problem solving to improve warehouse execution. Optimize slotting, travel paths, staging areas, space utilization, labor deployment, dock scheduling, and pick/pack flow. Manage third-party warehouses, carriers, couriers, destruction vendors, pest-control providers, and other logistics services through defined requirements and performance reviews. Drive improvements without compromising material status, traceability, security, temperature control, product quality, or patient safety. Warehouse Execution Receiving turnaround time and dock-to-quarantine performance. Production staging accuracy and on-time material delivery. Pick accuracy, pack accuracy, on-time shipment, and order cycle time. Warehouse productivity, overtime, space utilization, and backlog. Carrier tender and delivery-exception performance. Inventory and Compliance Inventory accuracy and cycle-count completion. Controlled-substance reconciliation and discrepancy performance. Material status and location accuracy. Cold-storage alarms, excursions, and response time. Warehouse, shipping, and material-handling deviations and recurrence. Training compliance, inspection readiness, and CAPA effectiveness. Required Qualifications Education Bachelor's degree in Supply Chain Management, Logistics, Operations, Business Administration, Life Sciences, or a related discipline preferred. An equivalent combination of education and directly relevant warehouse leadership experience may be considered. Experience Minimum of 7 years of progressive warehouse, distribution, inventory-control, or logistics experience, preferably in pharmaceutical, biotechnology, healthcare, medical device, or another regulated industry. Minimum of 3 years of supervisory or people-leadership experience preferred. Demonstrated experience with GMP receiving material status control, inventory accuracy, production staging, and finished goods shipping. Experience handling APIs, excipients, pharmaceutical components, consumables, labels, packaging materials, and finished drug products strongly preferred. Experience with DEA-controlled substances, cold-chain operations, direct-to-customer pharmaceutical distribution, or 503B operations strongly preferred. Experience supporting regulated inspections, investigations, CAPAs, recalls, and inventory audits preferred. Required Knowledge, Skills, and Abilities Strong knowledge of warehouse operations, material handling, inventory control, cycle counting, order fulfillment, and customer shipping. Working knowledge of cGMP warehouse controls, quarantine and release status, lot traceability, shelf-life management, temperature-controlled storage, and distribution records. Ability to apply controlled-substance security, access, inventory, recordkeeping, reconciliation, and shipping procedures in partnership with the DEA registrant and compliance resources. Strong ERP, warehouse management, barcode scanning, shipping-system, Microsoft Excel, reporting, and data-analysis skills. Strong root cause analysis, technical writing, process improvement, labor planning, and project execution skills. Excellent leadership, coaching, communication, and cross-functional collaboration skills. Ability to make timely decisions in a fast-paced operation while protecting safety, quality, security, compliance, and customer commitments. Preferred Qualifications APICS/ASCM CLTD, CPIM, CSCP, or equivalent certification. Lean Six Sigma, dangerous-goods, cold-chain, forklift-trainer, or controlled-substance training. Experience with SAP, Oracle, Microsoft Dynamics, or another validated ERP and a warehouse management system. Experience managing Schedule II-V controlled substances and supporting DEA inspections or required inventories. Experience with refrigerated and frozen storage, temperature-monitoring systems, qualified shipping containers, and excursion management. Experience with 503B compounded products, hospital or clinic customers, parcel carriers, couriers, and direct fulfillment. Physical Requirements Ability to sit, stand, walk, bend, reach, climb stairs, and move throughout warehouse, dock, cold-storage, and production-staging areas. Ability to enter refrigerated, frozen, controlled-access, GMP, and shipping areas and wear required PPE. Ability to visually inspect labels, containers, pallets, materials, packages, storage conditions, records, and computer screens. Ability to lift, carry, push, or pull materials or packages up to 25 #J-18808-Ljbffr