Job DescriptionPosition SummaryThe Warehouse Manager is responsible for the leadership, regulatory compliance, and continuous improvement of warehouse operations supporting manufacturing in an FDA-regulated environment. This role has end-to-end accountability for shipping, receiving, inventory control, and production material support, while ensuring full compliance with FDA regulations, cGMP/GxP requirements, and internal Quality Management Systems. The Warehouse Manager owns warehouse systems, processes, and performance outcomes, with a primary focus on continuous improvement, cost control, inventory integrity, audit readiness, and operational scalability.
Essential Duties & ResponsibilitiesWarehouse Leadership
- Own warehouse operations strategy supporting manufacturing, quality, and delivery objectives.
- Establish operating standards, capacity models, and performance expectations across shipping, receiving, inventory control, and production support.
- Ensure appropriate staffing models, labor planning, and organizational structure to support business demand and operational resilience.
Regulatory Compliance & Quality System Ownership
- Serve as the accountable owner for FDA compliance and cGMP/GxP adherence across all warehouse and material handling activities.
- Ensure warehouse SOPs, work instructions, and training curricula are current, effective, and audit-ready.
- Partner with Quality Assurance to support internal audits, FDA inspections, deviation investigations, CAPAs, and change controls impacting warehouse operations.
- Ensure proper controls for material status, lot traceability, FIFO/FEFO, shelf-life management, and segregation of non-conforming or restricted materials.
Inventory Control & Material Flow
- Own inventory accuracy, integrity, and availability across all material types supporting production and distribution.
- Establish and monitor cycle count programs, discrepancy resolution, and root-cause corrective actions.
- Ensure disciplined execution of ERP transactions, material staging, and production replenishment processes.
- Develop and track KPIs related to inventory accuracy, material availability, and service level performance.
Shipping & Receiving Oversight
- Provide oversight of inbound and outbound logistics operations.
- Ensure shipments and receipts meet regulatory, customer, and contractual requirements for documentation, labeling, packaging, and transport.
- Maintain oversight of DOT, FDA, and customer compliance requirements associated with distribution activities.
Continuous Improvement & Cost Reduction
- Identify, prioritize, and lead continuous improvement initiatives across safety, quality, delivery, inventory accuracy, labor productivity, and cost reduction.
- Apply Lean, Six Sigma, or structured problem-solving methodologies to eliminate waste, reduce variability, and improve process capability.
- Develop business cases for process improvements, automation, layout changes, or capital investments.
- Use data and KPIs to drive improvement and measure sustained performance gains.
Leadership & People Development
- Lead, coach, and develop warehouse supervisors to ensure strong execution, accountability, and succession readiness.
- Establish a culture of compliance, safety, continuous improvement, and operational discipline.
- Ensure training, qualification, and cross-training requirements are met to support operational flexibility.
Safety & Operational Standards
- Ensure warehouse operations meet OSHA, site safety, and environmental standards.
- Promote a safe, organized, and visually managed warehouse environment.
Knowledge, Skills & Qualifications- Expert knowledge of FDA regulations, cGMP/GxP requirements, and Quality Management Systems as applied to warehouse and materials operations.
- Advanced understanding of shipping, receiving, inventory control, and production material support in regulated manufacturing environments.
- Demonstrated ability to lead continuous improvement and cost-reduction initiatives with measurable results.
- Strong analytical skills with the ability to translate operational data into improvement priorities and executive-level insights.
- Proven leadership capability to influence supervisors and cross-functional partners across Quality, Manufacturing, and Supply Chain.
- Strong understanding of ERP-based inventory and material control systems.
- Excellent communication, organizational, and change-management skills..
Education and Experience - Must be 18 years of age
- Bachelor's degree in Supply Chain, Logistics, Business, Engineering, or related discipline; equivalent experience may be considered.
- Minimum 5-7 years of progressive leadership experience in warehouse or materials management; experience within an FDA-regulated manufacturing environment preferred.
- Experience supporting audits, CAPAs, deviations, and change controls related to warehouse operations.
- Experience leading multi-shift or 24/7 operations strongly preferred.
- Experience leading continuous improvement or operational excellence initiatives required
Physical Requirements and Work Environment- Work is performed in a combination of office and FDA-regulated manufacturing environments.
- The role requires regular presence in warehouse and production areas, including environments with automated robotics, forklifts, and other heavy equipment, while adhering to all safety requirements.
- Typically requires travel less than 5% of the time
