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

Major Accountabilities:

• 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

Knowledge, Skills or Abilities:

• 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

Minimum Education and Experience Requirements:

• 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)

Preferred Education and Experience Requirements:

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

Physical Demands:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 60 minutes.
• Ability to sit for prolonged periods of time up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 10 pounds.

*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 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.

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.

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).