Manager, Digital Technologies

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

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 programfor 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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

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

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:

Bachelors degree in science or engineering field with 8 years of experience in a GMP environment OR
Masters 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

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

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 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.

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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 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 programfor these ...