Manager, Supplier Quality

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

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 were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays 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 youll find a home here where your efforts directly improve patients lives. Together lets 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 70000 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: Description

What Youll 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:

Masters degree in quality business management or other related field with 5 years of experience; or
Bachelors 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

*#LI-Onsite

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 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.

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

Manager

Position OverviewThe 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 ...