Supply Chain Specialist 3, Compliance at FUJIFILM Holdings America Corporation

Holly Springs, NC 27540

About the Job

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

About This Role

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 coordinates and 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.

What You’ll Do

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 within the 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

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

Ability to sit for prolonged periods of time.

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email

FDBN_PNC@fujifilm.com

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.