Manager, SC Compliance & MDM

Position Overview

The Supply Chain Manager, Compliance & MDM will lead a team of operational and strategic associates to ensure data quality and integrity in Supply ChainGxP Compliance and SAP Master Data. Responsibilities include overseeing compliance and GMP/cGMP matters, managing supply chain-related deviationsand change controls, and supporting business process development. The role also involves managing SAP Master Data, including material masters andproduction resources. The manager formulates and aligns team strategies with higher-level goals, sets directions, prioritizes tasks, and ensures sufficientstaffing and team wellbeing. The candidate will initiate and lead global initiatives for processes and system alignment across sites for vendor changenotification, SAP master data and supplier complaint.

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

• Managing team by setting direction, supporting with key operational & strategic issues, and ensuring necessary information gets escalated• Leading and managing efforts to reach master data & compliance targets related to data quality level and completion. Perform owning departmenttasks for department as required to ensure compliance with PQS• Engage with various stakeholders to identify and drive key initiatives for continuous improvements to the SAP master data processes andcompliance levels within supply chain; resolving issues as required. Participate in SAP Change Advisory board and various projects and initiativesacross multiple functional areas and regions to manage prioritization & impact.• Manage team development opportunities through goal creation, alignment with company requirements, knowledge, and skill enhancements• Oversee data management tasks within Supply Chain GxP Compliance and SAP Master Data.• Ensure accurate creation and maintenance of master data, including material masters, BOMs, and production resources.• Provide support for compliance and GMP/cGMP matters within supply chain operations.• Manage supply chain deviations, CAPAs, change controls, and vendor change management.• Oversee compliance with FDBN warehouses and third-party logistics providers.• Manage supplier complaint processes and ensure alignment with compliance standards.• Support the development of compliant supply chain business processes.• Create and revise SOPs and work instructions as needed.• Support the development of compliant supply chain business processes.• Create and revise SOPs and work instructions as needed

 

Knowledge, Skills or Abilities• Ability to analyze complex data sets, identify trends, and make data-driven decisions. Proficiency in forecasting and predictive analytics is essential.• Capable of developing and implementing long-term strategies that align with business goals and adapt to changing market conditions.• Strong skills in identifying issues and developing innovative solutions to optimize supply chain operations and address disruptions.• Proficiency in managing multiple projects simultaneously, ensuring they are completed on time and within budget while meeting quality standards.• Excellent verbal and written communication abilities to effectively interact with cross-functional teams, and stakeholders at all levels.• Ability to lead, motivate, and develop a team, fostering a collaborative and high-performance work environment.• Familiarity with supply chain management software (e.g., SAP) and data analytics tools to enhance decision-making processes.• Capacity to adapt to rapid changes in the market and effectively manage stress and uncertainty, ensuring continuous improvement and operationalexcellence.• Proficiency in SAP Master Data management, including material masters, BOMs, and production resources.• Ability to ensure data accuracy and integrity through effective processes and controls• Comprehensive understanding of GxP and GMP/cGMP compliance requirements, particularly within supply chain operations.• Familiarity with regulations and best practices for data integrity and quality managemen

 

Basic Requirements

 

• A bachelor’s degree in supply chain management, businessadministration, logistics, operations management, or a related fieldand 7 years of experience• +3 years of experience leading people and/or cross-functional teams

 

Preferred Requirements

 

• A master’s degree or MBA could be advantageous for strategic roles.

 

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 ([email protected]).