Supply Chain Specialist , Compliance

Position Overview

The Supply Chain Specialist 3, Compliance is responsible for actions, processes, and audit readiness. This role supports all Supply Chain operations,procedures, systems, processes, and GXP related matters in accordance with the GXP requirements. The SC Specialist 3, Compliance initiates and investigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventative actions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints.

This role coordinate sand is responsible for leading internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements. The SC Specialist, Compliance will be coordinating change management record (CMR) for new raw material enrollment, supplier complaints and vendor change notifications.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles". Visit:

• Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization
• Leads optimization projects to ensure continuous process improvements and development for the organization and/or client
• Manages the analysis, revision, and resolution for master data issues, including inventory, SAP processes, cycle counting and other processes withinthe Supply Chain function
• Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement activities for Drug Substance and Drug Product
• Leads complex investigations when needed and drives actions through cross functional team
• Engages in teams to update SOPs, implement CAPAs, perform investigations and lead these, as needed
• Creates or revises SOPs and/or Work Instructions to support all Supply Chain Operations and functions
• Leads and supports implementation and maintaining the Vendor Change Notification, Supplier Complaint, and Material Enrollment processes
• Coordinates and leads teams within multiple functions and participate in projects/initiatives for Supply Chain support (e.g., SAP, Warehouse,Shipping/Logistics, Master Data, Weigh Dispense and Raw Material Sampling)
• Collaborates with cross functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, or project initiatives
• Ensures data integrity and compliance for operations and audit readiness
• Performs other duties, as assigned

• High School or GED and 9+ years of relevant work experience, or
• Bachelor’s degree in…