Manager, Digital Technologies

Fujifilm•Holly Springs, NC

About The Position

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

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

Nice To Haves

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

Responsibilities

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.