Supply Chain Specialist 3, 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 andinvestigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventativeactions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinatesand is responsible for leading internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customerrequirements. The SC Specialist, Compliance will be coordinating change management record (CMR) for new raw material enrollment, supplier complaintsand vendor change notifications.

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

• Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicabledocumentation 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 continuousimprovement 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, complianceactions, or project initiatives• Ensures data integrity and compliance for operations and audit readiness• Performs other duties, as assigned

Basic Requirements

• High School or GED and 9+ years of relevant work experience, or• Bachelor's degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field with 5+ years relevant work experience

Preferred Requirements

• Master's degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field with 3+ years of relevant work experience• Experience in quality management systems (e.g., SAP S4/HANA, Trackwise, Veeva)• Experience with GMP regulations, audits with FDA or similar organization management

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

PHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection X No YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No YesWill work in environment operating a motor vehicle or Powered Industrial Truck. X No YesAbility to discern audible cues. X No YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No YesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc. X No YesAbility to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240minutes)Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240minutes)Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. X No YesAbility to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No YesENVIRONMENTAL CONDITIONSWill work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)Will work in outdoor elements such as precipitation and wind. X No YesWill work in small and/or enclosed spaces. X No YesWill work in heights greater than 4 feet. X No

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).