Quality Assurance Disposition Manager

Fujifilm•Research Triangle Park, NC

11d•Onsite

About The Position

The Quality Assurance (QA) Disposition Manager is responsible for the disposition of both clinical and commercial manufactured products (intermediates and Active Pharmaceutical Ingredients (APIs)) ensuring products are produced and analyzed in accordance with FUJIFILM Biotechnologies procedures and Current Good Manufacturing Practice (CGMP) regulations while making recommendations as needed to release or reject manufactured materials that are manufactured at the site. This role organizes, maintains, and communicates the status of batch disposition details, and partners cross-functionally, including with external stakeholders to meet the dynamic needs of the customers programs. 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

Requirements

Effective communication, both written and oral
Ability to effectively present information to others
Ability to collaborate, communicate, and provide feedback to others, including senior leaders
Demonstrated ability with deviations, events, and batch disposition documentation
Ability to interact with regulatory agencies outside of and during inspections
Knowledge of SAP, TrackWise, MasterControl, or other GMP software
Ability to identify acceptable materials for GMP use
Knowledge of manufacturing processes, equipment, facilities, and utilities, and is well-versed in Quality Systems
Willingness to provide on floor presence to maintain familiarity of programs and to support teams
Must be flexible to support 24/7 manufacturing facility
Bachelor’s degree in life science or relevant field with 8 years of applicable industry experience; or Master’s degree in life science or relevant field with 6 years of applicable industry experience; or
Experience in a CGMP Manufacturing, Validation and/or Quality role in a Food & Drug Administration (FDA) regulated facility
Previous experience with disposition of biotechnology manufactured Active Pharmaceutical Ingredient (API) or Drug Product (DP)

Nice To Haves

Master’s degree in life science or relevant field
Experience working in a contract manufacturing organization

Responsibilities

Dispositions manufactured materials, ensuring regulatory compliance and patient safety
Determines batch impact and analysis from deviations, change controls, supplemental test results and facility, environmental monitoring and utility conditions as part of contextual review
Performs pre-production activities, including review and approval of Master Batch Records (MBR), Batch Material Masters (BMM) in SAP, Sampling Plan, item specifications and other documents
Coordinates or leads the Material Review Board (MRB) process and participates in customer audits, inspections, and Product Quality Review (PQR), as needed
Partners cross-functionally regarding technical issues and provides technical expertise related to batch dispositions and deviations
Ensures required information is obtained to successfully complete the review and approval of documents
Partners routinely with management and technical experts to address issues and create workable solutions while maintaining quality standards
Reviews and approves major and Out-of-Specification (OOS) deviations with potential batch impact, ensuring the associated investigations are complete, clear, and written to support Customer and Regulatory acceptance
Provides timely communication and responses to internal and external customers for product related deliverables
Delivers high throughput, high quality, and right first-time actions while implementing continuous improvement initiatives to support this effort
Performs other duties, as assigned