Position Overview

The Manager, Supplier Quality and Material Control ensures supplied materials meet company standards through a combination of auditing suppliers’ quality systems, inspecting, and analyzes quality data, and collaborative problem-solving with suppliers and internal teams to resolve issues while implementing continuous improvement initiatives. The Manager is responsible for the inspection and release of all Good Manufacturing Practice (GMP) consumables, raw materials, and labeling manufactured product, in addition to the release of manufacturing utilities, rooms, and equipment used in manufacturing processes and maintenance of the QA retention program. This role interacts with regulatory agencies during compliance inspections, manages supplier change notifications, deviations, corrective and preventive actions (CAPAs), and change controls while partnering with engineers, management and room owners. Additionally, the Manager provides leadership to quality specialists and ensures the team is position to successfully support a 24/7 manufacturing facility.

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

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:

• Manages a team of quality specialists and determines priorities to ensure successful completion of projects and tasks
• Problem solves on supplier change notifications and deviations to determine effective solutions and root causes
• Coordinates the Vendor Change Notification Committee
• Approves all Raw Material and Consumable Item Specifications
• Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectiveness
• Serves as the QA point of contact for Warehouse, Planning, and QC Raw Material escalations
• Reviews and approves relevant Material Control, Warehouse, QC Raw Material, standard operating procedures (SOPs) and STMs
• Supports client and regulatory inspections and serves as the subject matter expert (SME) for deviations, CAPAs and change controls, as needed
• Evaluates direct reports performance and addresses gaps appropriately while partnering with HR, as needed
• Provides metric and key performance indicators (KPIs) updates to the QMR lead
• Provides Quality assessments for materials related deviations, lab investigation and change controls
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Performs other duties, as assigned

Minimum Requirements:

• Master’s degree in quality, business management or other related field with 5+ years of experience; or
• Bachelor’s degree in quality, business management or other related field with 7+ years of experience; or
• 2-5 years of people management experience
• Prior experience working in a CDMO

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 (HR_FDBU@fujifilm.com).