The Manager, Digital Technologies will be responsible for managing the QA Digital Technologies team, including Quality oversight of IT and Automation (OT) systems through to operational readiness, as well as oversight of the execution of the computer system validation program for these systems. This role will collaborate within the Digital Technologies (DT) Quality team, as well as with other project teams and QA departments at other FLB sites, with a focus on consistent policy administration, QA oversight of day-to-day activities, and resolution or mitigation of issues occurring during operations.

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

What You’ll Do

• Provides directional QA oversight to the DT QA team in support of project deliverables and timelines in accordance with governing processes, and procedures for the DT program.
• Assesses the impact of system and process modifications and maintain oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides directional oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Reviews and approves QA procedures as well as related training for validation approach and lifecycle documents for IT and Automation (OT) systems, as well as primary responsibility for maintaining and updating training curricula for the DT QA team.
• Ensures that training is kept up to date by the DT QA team
• Ensures that project and operational Quality objectives are met within desired timelines.
• Collaborates and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Develops and supports start up activities into operations as the project matures, such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections.
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned.

Minimum Requirements:

• Bachelor’s degree in science or engineering field with 8+ years of experience in a GMP environment OR
• Master’s Degree science or engineering with 6+ years of experience in GMP environment OR
• 4+ years of people management experience
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• Working knowledge of ASTM E2500, CSV/CSA, and ALCOA+.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11/Annex 11Development, etc. with a focus on content design, delivery and program management

Preferred Requirements:

• 5+ years of experience working in a regulated GMP environment
• 6 years+’ experience in a role with oversight of IT GxP systems validation and lifecycle.
• Prior experience with an electronic validation EDMS platform (e.g. Kneat).
• Previous experience with personnel management in a GxP facility
• Prior experience with change management, deviations, CAPAs
• Previous experience with the following processes preferred:
  • Infrastructure (IT and/or OT related)
  • QC IT Systems (e.g. Empower, SoloVPE, PLA, LIMS, LabX)
• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes

Ability to stand for prolonged periods of time. minutes)

No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240

Ability to sit for prolonged periods of time. minutes)

No X Yes Daily up to 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No x Yes

Ability to operate machinery and/or power tools. x No Yes

Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes, x 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No x Yes

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 (FDBN_PNC@fujifilm.com).