Position Summary:

The Manager, Plasma Operations manages plasma supply strategies to support operations and maximize process efficiency and productivity. Oversees and supports all Plasma Operations activities, supervises staff, creates and maintains SOP’s and related documents for supply chain processes, such as plasma shipments, lookbacks, specialty programs, pool creation and plasma inventory reconciliation coordinates intermediate shipments to domestic and international customers.

Essential Functions (ES) and Responsibilities:

• Oversee and approve pool building and preparation for all IgG manufacturing.  Work closely with production planning, Warehouse-Plasma Freezer Team, Mfg. and QA for pool creation, approval, scheduling and consumption. 
• Responsible for supporting the procurement, logistics and control of human source plasma shipments from approved US plasma centers to approved off-site storage facilities through to the Boca manufacturing facility to meet the ADMA production schedule.  Monthly tracking of plasma supply vs forecast to ensure adequate plasma supply. 
• Oversee the plasma lookback process to ensure adherence to regulatory requirements. Works closely with Plasma QA and Regulatory for plasma vendor notifications and compliance.
• Review and approve monthly reconciliation of soft goods and plasma inventory for Sarbanes Oxley requirements and Inventory Controls.
• Work with Quality and Regulatory for investigations, deviations, and the change control processes associated with plasma activities.
• Relationship Manager for Interfaces with third party vendors and departments within the plasma operations processes.
• Oversee and review donor status for the RSV Program by providing oversight of the processing, testing and shipping screen and titer samples to the testing lab to meet program requirements and testing schedules.
• Partner with plasma suppliers to ensure specialty programs are managed efficiently.
• Support contract and approval process for Plasma Suppliers including annual Plasma Master File (PMF) review and reporting.
• Maintain and oversee procedures for all supply chain plasma operations to ensure all regulations are met and the plasma supply is maintained in a state of compliance.

Education & Experience Requirements:

Education Requirements:

• Bachelor’s or associate degree in business, Supply Chain or related field.

Experience Requirements:

• Minimum of 5 years of progressive experience in related position with in-depth knowledge of inventory management, plasma industry and manufacturing.
• High proficiency in office software packages, including word processing, spreadsheets, and SAP required. 

Preferred Experience:

Minimum of 5 years of progressive experience in related position with in-depth knowledge of inventory management, plasma industry and manufacturing.

Compliance Requirements:

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.