The Warehouse Manager is responsible for establishing, operating, and leading the pharmaceutical warehousing function. This position manages day-to-day warehouse operations while developing and implementing procedures aligned with cGMP and ICH Q7 requirements. The role initially operates as an independent, hands-on function with responsibility for creating compliant processes, material handling workflows, and documentation. Over time, this position will build and supervise a team of inventory control specialists, GMP material handlers, and logistics personnel to support operations as they scale. The Manager is accountable for ensuring compliance, operational efficiency, and consistent execution of warehouse and supply chain activities.
Requirements
Startup Operations Phase- Execute and manage all day-to-day warehouse activities including receiving, sampling coordination, storage, inventory management, and shipping of raw materials, consumables, intermediates, and finished products.
- Ensure strict adherence to GMP, DEA, FDA, and DSCSA compliance requirements from the outset.
- Create and implement SOPs, Work Instructions, and training documentation in accordance with ICH Q7 Section 10 and internal QMS.
- Operate SAP (WM/IM/MM) to perform and document material movements and status changes.
- Handle hazardous materials per regulatory requirements.
- Establish secure material segregation zones (ambient, refrigerated, flammable, DEA/cage).
Transition to Leadership & Strategic Oversight- Recruit, train, and lead a high-performing warehouse team including material handlers, inventory control specialists, transportation, and shipping/receiving coordinators.
- Establish KPIs and performance metrics for inventory accuracy, order fulfillment, on-time shipments, safety, and cost efficiency.
- Oversee the development and execution of warehouse layout planning, material flow, space optimization, and process improvement initiatives (e.g., Lean/Kaizen).
- Lead internal audits and support external inspections from regulatory authorities.
- Collaborate cross-functionally with Quality, Manufacturing, Planning, Procurement, and Regulatory Affairs to ensure seamless material flow and data integrity.
- Drive continuous improvement in safety practices, documentation accuracy, and operational performance.
Required Qualifications:- Bachelor's degree in Supply Chain, Operations, Business, or related field preferred. Associate's degree with relevant experience considered.
- 5-8+ years of warehouse experience in a regulated pharmaceutical or biotech GMP environment.
- 2-3+ years of experience in a supervisory or management role with demonstrated team-building ability.
- Direct experience managing cold chain logistics, hazardous materials, and DEA-controlled substances.
- Advanced user of SAP (especially WM/IM/MM modules) and strong proficiency in Excel and inventory analytics.
- Strong knowledge of GMP, ICH Q7/Q10, DSCSA, and 21 CFR Part 1301.
- Proven ability to write SOPs and execute warehouse compliance documentation.
Key Competencies:- Strategic thinker with operational agility and startup mentality.
- Capable of working independently and scaling toward team leadership.
- Attention to detail, documentation accuracy, and audit readiness.
- Strong interpersonal and communication skills across all organizational levels.
- Ability to drive a culture of safety, compliance, and continuous improvement.
Physical and Work Environment Requirements:- Must be able to lift up to 45 lbs (assisted as needed for >45 lbs).
- Regular walking, bending, lifting, and use of warehouse equipment.
- Work in ambient and refrigerated environments as needed.
- Use of RF scanners, pallet jacks, forklifts (certification preferred), and computers.
