Job Summary:The Warehouse Operations Manager is responsible for the Warehousing, Shipping, and Receiving functions and ensuring compliance with internal procedures and external standards are The position oversees all aspects of the company's pharmaceutical warehouse activities, including the storage and distribution of raw materials, intermediates, and finished products. The primary objective is to ensure efficient operations while maintaining strict adherence to all applicable regulatory standards, such as Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and FDA regulations.
Essential Duties:- Team Leadership & Management:
- Direct the warehousing and receiving staff and/or functions.
- Responsible for providing regular performance feedback, development, and coaching for direct reports.
- Responsible for obtaining and maintaining a Designated Representative certification for MannKind's State Licensing program for the sale and distribution of pharmaceutical and medical devices.
- Shipping & Receiving Operations:
- Supervise receipt and shipment from suppliers.
- Assure systems are in place to reconcile orders.
- Prepare records of receipt for incoming materials and equipment in accordance with SOX requirements.
- Responsible for the accuracy of all shipping documents (bills of lading, computer entry and tracking, inventory records, receiving reports, stock location tags, returned goods records, etc.).
- Collect and disseminate information for claims on in-transit damaged materials.
- Inventory & Storage Management:
- Responsible for maintaining MannKind's Danbury Site as a Foreign Trade Zone (FTZ) according to USCBP rules and regulations
- Supervise internal transfer of materials and ensure appropriate procedures are in place to meet internal quality and financial compliance.
- Supervise warehousing of materials and assure all materials are stored in compliance with quality, environmental and safety procedures.
- Develop ways to increase capacity within space constraints.
- Quality & Compliance:
- Ensure compliance with cGMPs, SOX, FDA, FAA, ISO and OSHA regulations.
- Write and/or review SOPs, as needed.
- Represent Warehouse Operations in internal and external audits.
- General Operations & Safety:
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
- All other functions within Warehouse Operations including special projects requested by Management.
Qualifications:
- BA/BS in a technical discipline with 7-10 years of experience in a regulated pharmaceutical environment or MS/MBA with 5-7 years related experience or an equivalent combination of training and related experience
- 7 years management experience, preferably in a cGMP warehouse environment
- Strong leadership, management, problem-solving, and organizational skills. Excellent attention to detail and communication skills.
- Deep expertise in cGMP, GDP, FDA, DSCSA, SOX, OSHA, and other relevant regulatory requirements for material handling and logistics. Experience presenting during audits/inspections is required.
- Experience with inventory management and control
- Knowledge of IATA, DOT shipping and HAZWOPER procedures
- The ability to effectively use PC software applications, such as MS Word, Excel, PowerPoint, Project, MRP applications etc.
- Ability to work independently with minimal supervision
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)Pay Range: $116,000 - $174,000 per year
