About The JobWe are seeking an experienced Warehouse Manager to lead all warehouse operations, manufacturing support, finished goods receipt/distribution, and compliance activities at our Boston cGMP facility. This role is critical to maintaining compliance with FDA 21 CFR 211, DEA regulations for controlled substances (Schedules II-V), USP hazardous drug handling, DSCSA, and Massachusetts Board of Pharmacy requirements.
Key Responsibilities- Oversee daily warehouse operations including receiving, put-away, picking, kitting, shipping, inventory control, and cycle counting in a temperature-controlled (2-8°C, -20°C, and ambient) environment.
- Lead the picking and staging of raw materials/components for manufacturing process orders: ensure 100% batch/lot traceability, FIFO/FEFO issuance, accurate weighing/scanning in AX, on-time delivery to production, and full cGMP documentation (pick lists, Production orders and deliveries).
- Oversee receipt of finished goods from manufacturing, perform receipt verification (quantity, labeling, damage checks), quarantine if required, and execute put-away into appropriate storage zones while maintaining cold-chain integrity and full traceability in AX.
- Own biowaste disposal processes: oversee segregation, secure storage, documentation, confirmation of destruction and coordination with licensed disposal vendors in compliance with EPA, DOT, DEA (if applicable), Massachusetts DEP, and facility permits.
- Develop, manage, and control the annual warehouse department budget (labor, OT, supplies, equipment maintenance, waste disposal, freight); track variances monthly and implement cost-saving initiatives while maintaining compliance and service levels.
- Manage outgoing distribution of finished goods: order fulfillment, accurate picking/packing/labeling, cold-chain packaging, carrier coordination, on-time shipping, and proactive alignment with sales forecasts and customer commitments to achieve 98%+ OTIF (On-Time In-Full) and support revenue goals.
- Ensure full compliance with DEA regulations for controlled substances (receiving, storage, security, dispensing, biennial inventory, ARCOS reporting, theft/loss reporting, power of attorney).
- Manage the AX (Microsoft Dynamics 365) ERP system for all inventory transactions, lot traceability, FIFO/FEFO, quarantine/release, and serialization/pedigree.
- Lead and develop a team of 10-18 warehouse technicians; responsible for hiring, training, performance management, and scheduling (including overtime/weekend coverage).
- Own change management and problem management: author/assess/implement change controls and lead root-cause investigations/CAPA for warehouse deviations, discrepancies, and complaints.
- Maintain cGMP storage conditions, cold-chain integrity, pest control, and environmental monitoring.
- Coordinate with Quality Assurance on material release, deviations, CAPA, recalls, and mock recalls.
- Achieve and sustain >99.5% inventory accuracy through cycle counts and reconciliations in AX.
- Manage 3PL relationships, freight carriers, and reverse logistics.
- Own warehouse KPIs: on-time receiving, on-time to production, on-time shipping/OTIF, inventory accuracy, labor productivity, cost per order/line, waste disposal compliance, budget variance, safety incidents.
- Drive continuous improvement projects (5S, lean, layout optimization, automation).
Basic Qualifications- Bachelor's degree in supply chain, logistics, business, or related field (or equivalent experience).
- 7+ years of warehouse leadership experience in a pharmaceutical, biotech, or other FDA-regulated environment.
- 3+ years of hands-on experience with Microsoft Dynamics AX or Dynamics 365 in a GMP setting (strong preference for AX 2012 R3 or D365 F&O).
- Proven track record handling DEA controlled substances (Schedules II-V) with full compliance.
- Demonstrated experience managing picking for manufacturing, finished goods receipt/put-away, biowaste disposal, department budgeting, and distribution to sales targets in a cGMP environment.
- Strong knowledge of cGMP (21 CFR 210/211), GDP, USP / , DSCSA track & trace, and cold-chain management.
- Experience managing refrigerated and frozen storage (validated coolers/freezers).
- Proven ability to achieve and maintain >99% inventory accuracy and 98%+ OTIF in an ERP-driven environment.
- Excellent leadership, people-development, and cross-functional collaboration skills.
Preferred Qualifications- APICS CPIM / CSCP / CLTD or similar supply-chain certification.
- Experience in 503A or 503B pharmaceutical compounding facilities.
- Formal training in root cause analysis and change control processes.
- Six Sigma Green Belt or Black Belt certification.
- Experience with cost-center budgeting and freight bid/RFP processes.
What's on Offer?Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.
At Fagron, you'll find plenty of chances to grow - both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.
